Endurant II/IIs Stent Graft System

P100021S063 · Medtronic Vascular · MIH · Sep 29, 2017 · Cardiovascular

Device Facts

Record IDP100021S063
Device NameEndurant II/IIs Stent Graft System
ApplicantMedtronic Vascular
Product CodeMIH · Cardiovascular
Decision DateSep 29, 2017
DecisionAPPR
Device ClassClass 3
AttributesTherapeutic, Real-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
P100021S063 · Sep 29, 2017Endurant II/IIs Stent Graft SystemMedtronic VascularANCHOR Registry (Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry); Standard of care clinical imaging and medical recordsThe ANCHOR Registry provided real-world data on the safety and effectiveness of the Endurant II/IIs Stent Graft System used in conjunction with the Heli-FX EndoAnchor System for treating abdominal aortic aneurysms with short infrarenal necks (≥ 4 mm and < 10 mm). The data were used to support the PMA indication expansion.ANCHOR Registry; Short Neck Cohort; Real-world evidence; Post-market registry; Standard of care

Clinical Evidence

Study DesignPopulationComparatorKey Endpoints
ANCHOR Registry (Short Neck Cohort); Prospective, observational, international, multi-center, post-market registry; prospectively defined retrospective analysis; Follow-up/Duration: Up to 5 years (1-month and 12-month data used for PMA); Study Period: May 19, 2012 to December 31, 2015Subjects with infrarenal neck length ≥ 4 mm and < 10 mm treated with Endurant or Endurant II/IIs Stent Graft Systems and Heli-FX EndoAnchors; Sample Size: 70; Number of Sites: 22Not applicable for this studyTechnical success rate, Type Ia endoleak rate at 1 and 12 months, re-intervention rate through 12 months

Indications for Use

The Endurant II/IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs Stent Graft System is indicated for use in patients with the following characteristics: Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; Proximal neck length of ≥ 10 mm; or ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only); Infrarenal neck angulation of ≤ 60°; Aortic neck diameters with a range of 19 to 32 mm; Distal fixation length(s) of ≥ 15 mm; Iliac diameters with a range of 8 to 25 mm; Morphology suitable for aneurysm repair.

Device Story

Endurant II/IIs Stent Graft System treats abdominal aortic aneurysms (AAA) via endovascular approach; self-expanding nitinol/polyester stent graft provides conduit for blood flow, excluding aneurysm sac. System includes modular stent graft and delivery system; advanced over guidewire to aneurysm site. For short infrarenal necks (≥ 4 mm and < 10 mm), system used with Heli-FX EndoAnchor System (K102333) for augmented fixation/sealing. Heli-FX uses catheter-based applier to place nickel-cobalt alloy anchors into aortic wall. Procedure performed by physicians in clinical setting under fluoroscopic guidance. Output is permanent exclusion of aneurysm; benefits include reduced rupture risk for patients unsuitable for open surgery. Clinical decision-making informed by imaging (CT/MRA) to verify seal and monitor for endoleaks/migration.

Clinical Evidence

Prospective, observational, multi-center registry (ANCHOR) analyzed 70 subjects with short infrarenal necks (≥ 4 mm and < 10 mm). Primary endpoints: technical success, Type Ia endoleak rate, re-intervention rate. Results: 88.6% technical success; 6.8% Type Ia endoleak at 1 month, 1.9% at 12 months; 4.7% re-intervention rate through 12 months. No aneurysm rupture or conversion to open repair through 12 months. 5.7% aneurysm-related mortality through 30 days. Evidence supports benefit-risk profile in high-risk (ASA III/IV) population.

Technological Characteristics

Modular stent graft: nitinol stents (laser-cut suprarenal, wire-formed distal) sewn to polyester fabric. Suprarenal stents use UHMWPE suture; others use polyester suture. Platinum radiopaque markers. Delivery system: Aortic and Iliac configurations. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients ≥ 18 years with adequate iliac/femoral access, proximal neck length ≥ 10 mm (or ≥ 4 mm and < 10 mm with Heli-FX EndoAnchor), neck angulation ≤ 60°, neck diameter 19-32 mm, and distal fixation length ≥ 15 mm. Contraindicated in patients with infection risk or known sensitivity to device materials.

Reference Devices

Submission Summary (Full Text)

{0} # SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) ## I. GENERAL INFORMATION Device Generic Name: Endovascular Graft Device Trade Name: Endurant™ II/Endurant™ IIs Stent Graft System Device Procode: MIH Applicant's Name and Address: Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 Date(s) of Panel Recommendation: None Premarket Approval Application (PMA) Number: P100021/S063 Date of FDA Notice of Approval: September 29, 2017 The Endurant Stent Graft System original PMA (P100021) was approved for the treatment of infrarenal abdominal aortic aneurysms on December 16, 2010. The Endurant™ II/Endurant™ IIs Stent Graft Systems (hereinafter referred to as Endurant II/IIs Stent Graft System) are next-generation stent graft systems based on Endurant. The Endurant II Stent Graft System received FDA approval on April 27, 2012 (P100021/S011). The Endurant IIs Stent Graft System received FDA approval on October 23, 2015 (P100021/S039). The Summary of Safety and Effectiveness Data (SSED) to support the original approval is available on the CDRH website (https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100021b.pdf) and is incorporated by reference here. The current supplement was submitted to expand the indication for the Endurant II/IIs Stent Graft System to include treatment of infrarenal abdominal aortic aneurysms having neck lengths ≥ 4 mm and < 10 mm (“short necks”), when used in conjunction with the Heli-FX EndoAnchor System (K102333). ## II. INDICATIONS FOR USE The Endurant II/IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be utilized in conjunction with the Heli-FX EndoAnchor System when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks. The Endurant II aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant II/IIs Stent Graft System is indicated for use in patients with the following characteristics: PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 1 {1} - Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories - Proximal neck length of - ≥ 10 mm; or - ≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX EndoAnchor System (bifurcated stent graft only) Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter. - Infrarenal neck angulation of ≤ 60° - Aortic neck diameters with a range of 19 to 32 mm - Distal fixation length(s) of ≥ 15 mm - Iliac diameters with a range of 8 to 25 mm - Morphology suitable for aneurysm repair ### III. CONTRAINDICATIONS The Endurant II/IIs stent graft system is contraindicated in: - patients who have a condition that threatens to infect the graft - patients with known sensitivities or allergies to the device materials When used with the Heli-FX EndoAnchor system, the Endurant II/IIs Stent Graft System is also contraindicated in: - patients with known sensitivities to the EndoAnchor implant materials For contraindications regarding ancillary devices used with the Endurant II/IIs stent graft system, refer to the instructions for use provided with each device. ### IV. WARNINGS AND PRECAUTIONS The warnings and precautions specific to the use of the Endurant II/IIs and to the use of this device in conjunction with the Heli-FX EndoAnchor System are included in the Endurant II/IIs Stent Graft System instructions for use. The warnings and precautions for the Heli-FX EndoAnchor System are also applicable for the expanded indication and can be found in the instructions for use for that device. ### V. DEVICE DESCRIPTION #### Endurant II/IIs Stent Graft System The Endurant II/IIs Stent Graft System is intended for the treatment of abdominal aortic aneurysms (AAA) using an endovascular approach. When placed within the target lesion, PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 2 {2} the stent graft (implant) self-expands to provide a permanent, alternative conduit for blood flow within the vasculature by excluding the aneurysmal sac from blood flow and pressure. The Endurant II/IIs Stent Graft System is comprised of two main components: an implantable stent graft and a disposable delivery system. The stent graft, preloaded into the delivery system, is advanced to the aneurysm location over a guidewire. Upon retraction of the graft cover, the stent graft self-expands to the indicated vessel diameter. During deployment and expansion, the stent graft is intended to form proximal and distal seal zones surrounding the aneurysm location. The Endurant II/IIs Stent Graft System stent graft is based on the Endurant stent graft. The Endurant II/IIs Stent Graft System comprises a product line extension. The differences in these devices are described in the Annual Physician Clinical Update for the Endurant/Endurant II/Endurant IIs Stent Graft Systems. All Endurant family aortic stent grafts (Endurant/Endurant II/Endurant IIs) are identical with respect to the design of the proximal end, including the suprarenal stent, anchor pins and sealing zone. There have been no changes in the stent graft system associated with the change in labeling to allow for the treatment of short necks when used with the Heli-FX EndoAnchor System. ### **Stent Grafts** The Endurant II/IIs Stent Graft System is modular. The component configurations affected by the change in indications for use include the following: - Bifurcated component (Endurant II and Endurant IIs) Each component is introduced separately into the patient’s vascular system. After the placement of the bifurcated and contralateral limb components, aortic and limb extension components may be introduced separately into the vessel and are mated *in vivo* to the components already *in situ*. All components are composed of nitinol metal stents sewn to a polyester fabric graft. The suprarenal stents with anchoring pins on the proximal end are laser cut from a nitinol tube. The remaining stents are formed in a ring with opposing ends being terminated together in crimp sleeves. These are called wire formed stents. The wire formed stents are sewn to the polyester graft fabric using a polyester suture, whereas the suprarenal stents are sewn to the graft fabric using an ultra-high molecular weight polyethylene suture. This suture is designed to aid in better stent to graft attachment strength, thus providing a more durable proximal attachment. Radiopaque markers, constructed of platinum, are sewn onto the stent graft to aid in visualization of the stent graft under fluoroscopy and to facilitate accurate placement of the device. Refer to **Figure 1** for an overview of stent graft components. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 3 {3} The stent graft is designed to be placed in the native vessel such that the unconstrained stent graft diameter is larger than the diameter of the native vessel into which it is to be placed. This “oversizing” helps to exclude the aneurysm from aortic blood flow and to ensure the stent graft is held in place. The amount of oversizing required is dependent on the diameter of the native vessel. ![img-0.jpeg](img-0.jpeg) Endurant II Bifurcated Stent Graft ![img-1.jpeg](img-1.jpeg) Endurant IIs Bifurcated Stent Graft ![img-2.jpeg](img-2.jpeg) Aortic Extension Stent Graft ![img-3.jpeg](img-3.jpeg) Limb Stent Graft ![img-4.jpeg](img-4.jpeg) Iliac Extension Stent Graft Figure 1. Relevant Endurant II and Endurant IIs Stent Graft Configurations PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 4 {4} ## Delivery Systems There are two types of delivery systems for the Endurant II/IIs Stent Graft System, the Aortic Delivery System and the Iliac Delivery System. The Aortic Delivery System is used to deliver the aortic extension, bifurcated, and AUI stent grafts. The Iliac Delivery System is used to deliver contralateral limbs and iliac extensions. See **Figure 2** and **Figure 3** below for an overview of the Aortic and Iliac Delivery Systems, respectively. ![img-5.jpeg](img-5.jpeg) **Figure 2. Endurant II/IIs Aortic Delivery System** PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 5 {5} ![img-6.jpeg](img-6.jpeg) | # | Components | # | Components | | --- | --- | --- | --- | | 1 | Taper Tip Assembly | 8 | Trigger | | 2 | Graft Cover | 9 | Front Grip | | 3 | RO Marker Band | 10 | Stent Stop | | 4 | Rear Handle | 11 | Back End T-Tube | | 5 | Screw Gear | | | | 6 | Strain Relief | | | | 7 | Slider | | | Figure 3. Endurant II Iliac Delivery System Please refer to the Physician Instructions for Use for additional details. ### Heli-FX EndoAnchor System The Heli-FX EndoAnchor System is a class II device cleared through the Premarket Notification [510(k)] process and is not part of this PMA. However, the expanded indications for use in this submission require the use of the Heli-FX EndoAnchor System in conjunction with the Endurant II/IIs Stent Graft System. The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. It is comprised of the EndoAnchor implant (an intravascularly-applied suture constructed of medical-grade nickel-cobalt wire, supplied in a cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier). Please see Figure 4, Figure 5 and Figure 6. It is recommended that the EndoAnchor implantation be done after the aortic endograft has been placed and any balloon remodeling of the infrarenal seal zone of the stent graft system has been completed. The recommended Heli-FX Guide tip configuration is based on native vessel diameter. The recommended number of EndoAnchor implants is based on endograft type, graft angulation and native vessel diameter. Further detail is available in the physician instructions for use for the Heli-FX EndoAnchor System and the Endurant II/IIs instructions for use. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 6 {6} ![img-7.jpeg](img-7.jpeg) Figure 4. Diagram of the Heli-FX Applier 1. Control handle 2. Catheter 3. Reverse control button 4. Forward control button 5. Green forward and reverse indicators 6. Error indicator 7. Flush port ![img-8.jpeg](img-8.jpeg) 1. Crossbar 2. Leading end Figure 5. Heli-FX EndoAnchor ![img-9.jpeg](img-9.jpeg) 1. Control handle 2. Guide catheter 3. Radiopaque markers 4. Deflector knob 5. Obturator 6. Hemostatic seal 7. Flush port Figure 6. Components of the Heli-FX Guide PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 7 {7} ## **VI. ALTERNATIVE PRACTICES AND PROCEDURES** There are several alternatives for the treatment of abdominal aortic aneurysms with short infrarenal necks including fenestrated endografts, another endovascular graft indicated for treatment of shorter necks, medical management, and open surgical repair. Each alternative has its own advantages and disadvantages. The physician should fully discuss these alternatives with his/her patient to select the method that best meets expectations and lifestyle. ## **VII. MARKETING HISTORY** Endurant II/IIs Stent Graft System is commercially available in the following countries: | Argentina | Guatemala | Philippines | | --- | --- | --- | | Australia | Hong Kong | Poland | | Austria | Hungary | Portugal | | Belarus | Iceland | Romania | | Belgium | India | Russia | | Bolivia | Indonesia | Saudi Arabia | | Bosnia and Herzegovina | Ireland | Serbia | | Brazil | Israel | Singapore | | Bulgaria | Italy | Slovakia | | Canada | Japan | Slovenia | | Chile | Jordan | South Africa | | Colombia | Kuwait | South Korea | | Costa Rica | Latvia | Spain | | Croatia | Liechtenstein | Sweden | | Cyprus | Lithuania | Switzerland | | Czech Republic | Luxembourg | Taiwan | | Denmark | Macedonia | Thailand | | Ecuador | Malaysia | Turkey | | El Salvador | Malta | UK/Northern Ireland | | Estonia | Mexico | Ukraine | | Finland | Netherlands | United States/PR | | France | New Zealand | Uruguay | | Germany | Norway | Venezuela | | Greece | Peru | Vietnam | A global voluntary recall of a limited number of Endurant and Endurant II stent grafts was initiated on March 2, 2017, due to varying fabric permeability in specific lots. To date, there have been no other market withdrawals of the Endurant, Endurant II and Endurant IIs Stent Graft Systems for reasons related to safety or effectiveness. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 8 {8} ### **VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH** Below is a list of the potential adverse effects (e.g., complications) that may be associated with the use of the Endurant II/IIs Stent Graft System or with the use of Endurant II/IIs Stent Graft System in conjunction with the Heli-FX EndoAnchor System, with those uniquely associated with the use of EndoAnchors listed under “EndoAnchor.” - Amputation - Anesthetic complications and subsequent attendant problems (eg, aspiration) - Aneurysm enlargement - Aneurysm rupture and death - Aortic damage, including perforation, dissection, bleeding, rupture and death - Arterial or venous thrombosis and/or pseudoaneurysm - Arteriovenous fistula - Bleeding, hematoma or coagulopathy - Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis) - Cardiac complications and subsequent attendant problems (eg, arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension) - Claudication (e.g., buttock, lower limb) - Death - Edema - Embolization (micro and macro) with transient or permanent ischemia or infarction - EndoAnchor (for infrarenal endovascular aneurysm repair (EVAR) procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage - Endoleak - Femoral-femoral artery bypass thrombosis - Fever and localized inflammation - Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection) - Hepatic failure - Impotence - Infection of the aneurysm, device access site, including abscess formation, transient fever and pain - Lymphatic complications and subsequent attendant problems (eg, lymph fistula) - Neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis) - Occlusion of device or native vessel - Pulmonary complications and subsequent attendant problems - Renal complications and subsequent attendant problems (eg, artery occlusion, contrast toxicity, insufficiency, failure) - Stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; thrombus; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 9 {9} - Surgical conversion to open repair - Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection. - Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death) - Vessel damage - Wound complications and subsequent attendant problems (eg, dehiscence, infection, hematoma, seroma, cellulitis) For the specific adverse events that occurred in the clinical studies, please see Section X (Summary of Primary Clinical Evidence) below. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 10 {10} ## IX. SUMMARY OF NONCLINICAL STUDIES Medtronic performed a risk assessment to identify the device attributes that could potentially be impacted by the proposed indication expansion and presented the rationale for the information needed to evaluate each of the attributes (i.e., existing test data or new testing). Nonclinical studies previously conducted continue to be applicable to and supportive of the use of the Endurant II/IIs Stent Graft System and the Heli-FX EndoAnchor System. Medtronic also conducted additional laboratory studies, summarized below, to confirm continued performance of the Endurant II/IIs Stent Graft System in conjunction with Heli-FX in the short neck application. ### A. Laboratory Studies #### In Vitro Bench Studies Medtronic performed the *in vitro* tests shown in the table below to confirm that Endurant II/IIs Stent Graft System continues to perform as expected when utilized in conjunction with Heli-FX EndoAnchors in the short neck application. **Table 1. In Vitro Bench Studies** | Test | Purpose | Acceptance Criteria | Result | | --- | --- | --- | --- | | Simulated Use | The purpose of the simulated use testing was to demonstrate that the Endurant II/IIs Stent Graft System and the Heli-FX system can be appropriately used in the proposed short neck anatomies following the currently approved implant procedures. Endurant II/IIs stent grafts and Heli-FX EndoAnchors were deployed in a test environment designed to simulate physiological conditions, utilizing fluoroscopic visualization only. A worst-case anatomical model that included the most challenging proximal neck anatomy coupled with the angulation that covers the limits of the indication was utilized. For Endurant II/IIs Stent Graft System, the following performance requirements were evaluated: deployment accuracy, ability to withdraw, migration resistance. For Heli-FX, the following performance requirements were evaluated: trackability, pushability, torqueability, flex/kink, deployment accuracy, ability to withdraw, EndoAnchor penetration. | The radiopaque marker on the guide can be tracked within the proximal seal zone of the Endurant II/IIs stent graft (proximal most stent). The system must be able to be pushed through simulated tortuous anatomies such that the radiopaque marker on the guide can reach the proximal seal zone of the Endurant II/IIs stent graft (proximal most stent). The tip of the system must be able to be rotated a full 360° while located at the proximal seal zone of the Endurant II/IIs stent graft (proximal most stent). The EndoAnchors must be successfully deployed at the deployment target. The operator must recapture the spindle and tapered tip, and the delivery system must be withdrawn, intact, from the simulated use model after stent graft deployment. The operator must be able to withdraw the Heli-FX applier and | All acceptance criteria were met. | PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 11 {11} | Test | Purpose | Acceptance Criteria | Result | | --- | --- | --- | --- | | | | guide from the simulated use model after deployment without dislodging the stent graft. EndoAnchor must penetrate through the stent graft, into the mock vessel, and remain attached to the mock vessel following removal of all delivery systems from the mock vessel. The stent graft shall not migrate more than 4mm during the full Simulated Use procedure. | | | Seal Testing | The purpose of this testing was to determine the seal performance of the Endurant II/IIs Stent Graft System in conjunction with the Heli-FX EndoAnchor system in the proposed indication expansion, under worst case conditions. Relative performance of Endurant II/IIs stent graft without EndoAnchor implants was also evaluated and lastly, a comparison to historical seal performance of Endurant II and Talent stent grafts was made. | Endurant II/IIs stent graft 4 mm Seal Performance with EndoAnchors is better than 35.93 g/sec. | Acceptance criteria were met. | ## Modeling Studies Medtronic performed the modeling studies described below to evaluate the fatigue strains occurring under the new use conditions. **Table 2. Modeling Studies** | Test | Purpose | Acceptance Criteria | Result | | --- | --- | --- | --- | | Finite Element Analysis (FEA) | The purpose of the analysis was to quantify the fatigue strains occurring in the Endurant II/IIs suprarenal and seal stents under the *in-vivo* loading conditions represented by the expanded indication. These strains are used to calculate estimates of fatigue safety factors. The modeling included the impact of other anatomical and use conditions (i.e. vessel wall conicality and stent oversizing) on the endurance limit of the system to confirm worst case configurations were utilized in the analysis. | Safety factors based on the endurance limits must be > 1.6. | All safety factors based on the endurance limit satisfied the acceptance criteria. | PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 12 {12} ## **X. SUMMARY OF PRIMARY CLINICAL EVIDENCE** Medtronic utilized real-world evidence to establish the safety and effectiveness of Endurant II/IIs Stent Graft System in conjunction with Heli-FX in abdominal aortic aneurysms (AAAs) for the treatment of short infrarenal necks. Information available from the ANCHOR Registry (Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (clinicaltrials.gov identifier NCT01534819)) was used. Although this is a prospectively enrolling registry, patient selection was retrospective for this analysis. The ANCHOR Registry enrolls subjects into either the Primary Group (utilization of Heli-FX EndoAnchor implants during initial endovascular treatment) or the Revision Group (utilization of Heli-FX EndoAnchors during a reintervention). Subjects are treated with endovascular grafts made by several manufacturers. Subjects enrolled in the Primary Group with neck lengths of $\geq 4$ mm and $< 10$ mm and treated with Endurant or Endurant II/IIs Stent Graft Systems comprised the study cohort, referred to as the 'Short Neck Cohort'. Information on subjects in the Primary Group with neck lengths $< 4$ mm and treated with any endovascular graft, and those with neck lengths of $\geq 10$ mm and treated with Endurant or Endurant II/IIs Stent Graft Systems is presented to provide context for the study cohort outcomes. Data from previous Endurant studies and a literature review are presented to further allow for interpretation of the study results. Data from this analysis were the basis for the PMA approval decision. A summary of the data are presented below. ### **A. Study Design** The ANCHOR Registry is a prospective, observational, international, multi-center, post-market registry. The study consists of a prospectively defined retrospective analysis. The Registry enrollment began in 2012 and is ongoing. As of June 15, 2016, 604 subjects were enrolled. Of these, a total of 70 subjects with a core lab-verified infrarenal neck length of $\geq 4$ mm and $< 10$ mm (defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter) were enrolled into the Primary Group and were treated with Endurant or Endurant II/IIs Stent Graft Systems. This group of subjects is referred to as the 'Short Neck Cohort'. The first Short Neck Cohort subject was enrolled on May 19, 2012. The 70th subject was enrolled on December 31, 2015. A total of 22 sites contributed subjects to the Short Neck Cohort; 19 of these were in the US and 3 were located in Europe. In order to obtain independent verification of imaging findings, standard of care imaging studies for the subjects in the Short Neck Cohort were sent by the investigational sites to Syntactx, the independent Imaging Core Laboratory for the ANCHOR registry. An independent Medical Monitor acted in an advisory capacity to monitor participant safety and data quality. The Medical Monitor may review imaging films, and/or the electronic data capture (EDC) entry and source documentation for site reported unanticipated adverse events (UADEs), serious adverse events (SAEs), and adverse PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 13 {13} events (AEs). The ANCHOR Registry does not use a clinical events committee (CEC) or data monitoring committee (DMC). This clinical study was not designed to measure a treatment effect against a control group or performance goal. Rather, it was designed to evaluate whether the Endurant II/IIs Stent Graft System with Heli-FX in the “short neck” use condition is clinically safe and performs as expected when compared to alternative short neck treatments reported in the literature or when compared to treatment with the Endurant II/IIs Stent Graft System in other use conditions. All endpoints were analyzed descriptively. No formal hypothesis test was planned for this study. To support the indication expansion and to provide additional context for discussion, data from supportive and reference cohorts were presented. Supportive cohorts included other cohorts from the ANCHOR Registry. The “Very Short Neck Cohort” is comprised of subjects in the primary treatment arm that were treated with any manufacturer’s stent graft system in an infrarenal neck of < 4 mm. The “On-Label Neck Length Cohort” is comprised of subjects in the primary treatment arm, treated with an Endurant or Endurant II/IIs Stent Graft System and Heli-FX and having an infrarenal neck ≥ 10 mm. In addition, ENGAGE¹ and Endurant IDE² results were presented as supportive cohorts to provide context of clinical results within patients that typically had infrarenal neck lengths that aligned with the current Endurant II/IIs Stent Graft System indications for use. Finally, a literature review was performed to assess the clinical results from short neck EVAR (snEVAR), fenestrated stent grafts (fEVAR), and chimney/snorkel procedures (chEVAR). These reference groups were selected as they comprise the most commonly used endovascular treatment modalities for the repair of short infrarenal neck aortic aneurysms, although the devices used in chEVAR are used off-label. 1. Clinical Inclusion and Exclusion Criteria All subjects in the Short Neck Cohort met the selection criteria for the Primary Group of the ANCHOR Registry. Additionally, subjects in the Short Neck Cohort were required to be treated with an Endurant or Endurant II/IIs Stent Graft System and have an AAA with an infrarenal neck length measured as ≥ 4 to < 10 mm by the core laboratory. Enrollment in the Primary Group of the ANCHOR Registry was limited to patients who met the following inclusion criteria: - Subject with asymptomatic, symptomatic or ruptured abdominal aortic aneurysm, - Subject ≥ 18 years old, - Subject has provided written informed consent either before or less than or equal to 30 days after the index procedure, - Subject is willing to comply with standard of care follow- up evaluations, ¹ The ENGAGE Global Registry is a prospective, single-arm, multi-center, non-randomized, non-interventional, global clinical registry. A total of 1263 subjects were enrolled from 2009 to 2011 at 79 centers globally. ² The Endurant Stent Graft System US Clinical Study (referred to as Endurant IDE Clinical Study) is a two-arm (Bifurcated and AUI), prospective, non-randomized, multicenter study designed to evaluate the safety and effectiveness of the Endurant Stent Graft System in the treatment of infrarenal abdominal aortic and aortoiliac aneurysms. The bifurcated arm completed first with 150 subjects enrolled across 26 sites in the United States. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 14 {14} - Subject's iliac/femoral access is compatible with a 16 French sheath, - Subject has a previously implanted AAA endograft (Revision Group), or will be undergoing repair (Primary Group), - Subject has a previously implanted Endograft that has migrated or has a Type Ia Endoleak (Revision Group), or - Subject has/will undergo implantation of EndoAnchor implants during initial endograft implantation due to, in the opinion of the investigator, an increased risk of Type Ia endoleak or migration (Primary Group) Patients were not permitted to enroll in the Primary Group of the ANCHOR Registry if they met any of the following exclusion criteria: - Subject has known allergy to the EndoAnchor implant material (nickel, chromium, molybdenum, or cobalt), - Subject has a life expectancy of less than 1 year, - Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety, - Subject has already been implanted with an EndoAnchor device in a procedure performed prior to the index procedure, - Subject has an active or known history of bleeding diathesis, - Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection), - Infrarenal aortic neck with significant thrombus or calcium that precludes adequate EndoAnchor penetration of the aortic wall, or - Use of EndoAnchor implants to secure one endograft component to another, without placing each EndoAnchor into the aortic wall. # 2. Follow-up Schedule ANCHOR Registry follow-up evaluations, including imaging, were scheduled per the Investigator's discretion and local standard of care. Data was collected for each subject enrolled from baseline and up to 5 years after the index procedure. Follow-ups at 30 days and 12 months were included in the outcomes analyses to support the short neck indication. Due to the nature of the ANCHOR Registry as a collection tool for real-world data completed as standard of care, time windows for visits were not defined or required in the protocol. For the purposes of the Short Neck Cohort evaluation, statistical analysis windows were defined broadly in order to include as many subjects as possible and present more complete follow-up information. For image-based assessments, such as stent-graft endoleak, migration and other imaging findings, the following time windows were applied: Implant: Day 0; Day 30: 1 – 183 days; Day 365: 184 – 913 days. The ANCHOR Registry allows for the capture of the following preoperative information: demographics, medical history/risk factors, ASA classification, aneurysm symptomology, reason for EndoAnchor use, and various anatomical and aneurysm measurements. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 15 {15} The ANCHOR Registry allows for the capture of the following postoperative information: procedural data, device components utilized, device delivery and deployment, endoleaks, device integrity (e.g., fracture, penetration) and reinterventions. Additionally, post-operative data on safety-related data including adverse events, device migration, mortality and aneurysm expansion are also collected. Imaging data is collected per standard of care and is evaluated per protocol by an imaging core lab. ### 3. Clinical Endpoints With regards to safety, the data from each device submitted in their respective marketing applications were extrapolated to the combination of the devices to treat short neck AAA. There was no primary safety outcome; however, morbidity and mortality were presented as safety supportive outcomes. With regards to effectiveness, outcomes of particular importance in evaluating the treatment success for short neck abdominal aortic aneurysms were selected for the analysis. The primary outcomes addressed the ability to accurately deliver and deploy the endovascular graft, achieve adequate sealing of the graft to the aorta, and maintain effectiveness without the need for additional interventions. The primary and supportive outcomes are listed below. Key additional outcomes that were reported in relation to AAA studies were also included in order to provide a broader view of the clinical results. All outcomes were analyzed descriptively. Success/failure criteria were not applied. Distribution frequencies described the qualitative parameters. Quantitative parameters were described by the mean, standard deviation, minimum, maximum, median, and number of subjects with assessable data. No available data were excluded from the analysis. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 16 {16} # **Procedure-Related Supportive Outcomes** *Index procedure-related measures* - Procedure time - Fluoroscopy time - Procedure success - Accessory devices used, and relation to any device- or procedure-related event # **Safety** # **Supportive Outcomes** *Safety-related measures* - Aneurysm-related mortality through 30 days and 12 months - Aneurysm rupture through 30 days and 12 months - Major adverse events through 30 days - Renal insufficiency through 30 days - Renal failure through 30 days *Additional outcomes* - All-cause mortality through 12 months - Major adverse events through 12 months - Serious adverse events through 12 months # **Effectiveness** # **Primary Outcomes** - Technical success rate - Type Ia endoleak rate at 1 month (core laboratory assessed) - Type Ia endoleak rate at 12 months (core laboratory assessed) - Re-intervention rate through 12 months # **Supportive Outcomes** *Device-related measures* - Evidence of endograft or EndoAnchor loss of integrity through 12 months - Impact of number of EndoAnchor implants used on the primary outcomes - Adequate maintenance of EndoAnchor implants into the aortic wall at 30 days and at 12 months *Effectiveness-related measures* PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 17 {17} - Aneurysm expansion at 12 months - Migration at 12 months - Re-interventions through 30 days - Conversion to open surgical repair through 30 days - Type III endoleaks at 30 days and 12 months # **B. Accountability of Short Neck Cohort** The ANCHOR Registry protocol collected data from standard of care follow-up visits and imaging. Visit windows were not prospectively defined. For the purposes of the Short Neck Cohort evaluation, statistical analysis windows were defined broadly in order to include as many subjects as possible and present more complete follow-up information. A core laboratory evaluated images from the sites to provide independent verification of findings. Since the method of image collection was completed per institutional standard of care, some imaging studies were inadequate for the core lab to assess specific parameters. A total of 88% (58/66) of subjects had 12-month imaging follow-up; however, only 54/66 (82%), 53/66 (80%), and 41/66 (62%) subjects had adequate imaging to assess aneurysm size increase, Type Ia endoleaks, and migration, respectively. To allow for an alternate evaluation of migration, imaging assessments were supplemented by review of adverse event reports and reasons for re-intervention. Among the 25 subjects lacking adequate imaging to assess migration, there was one core lab-reported Type Ia endoleak, which required a secondary endovascular repair. The absence of interventions that could be associated with a migration supports the likelihood that the other 24 patients did not experience migration within 12 months; however, migration assessments for 16 subjects were not available due to a lack of adequate 30-day imaging in 7 subjects and study exit in 9 subjects. Clinical follow up of the Short Neck Cohort was greater than 90% at both the 1-month and 12-month time points. Considering the levels of evaluable imaging that were achieved, from a statistical perspective, 10% estimation precision was still reached in every 95% confidence interval of the primary outcomes, as planned. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 18 {18} **Table 3. Subject and Imaging Accountability** | Interval (Analysis Window) | Subject follow-up | | | | Subjects with imaging performed | | | Subjects with adequate imaging to assess the parameter^{1} | | | Subject events occurring before next visit | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Eligible^{2} | Clinical Follow-up | Imaging Follow-up | Subjects with follow-up pending^{3} | CT Imaging^{4} | KUB Imaging | Duplex Ultrasound | Aneurysm size increase | Endoleak | Migration | No Implant | Death | Withdrawal/Early Termination | Lost to Follow-up | | Originally Enrolled | 70 | | | | | | | | | | 0 | 0 | 0 | | | 1 Month (Day 1- 183) | 70 | 64 (91%) | 62 (89%) | 0 (0%) | 60 (86%) | 12 (17%) | 19 (27%) | | 59 (84%) | | | 4 | 0 | 0 | | 12 Months (Day 184- 913) | 66 | 61 (92%) | 58 (88%) | 0 (0%) | 43 (65%) | 13 (20%) | 32 (48%) | 54 (82%) | 53 (80%) | 41 (62%) | | 8 | 3 | 1 | | Based on number of all enrolled subjects within the Short Neck Cohort with available data. | | | | | | | | | | | | | | | | ^{1} Not the number of subjects with these reported events, but rather, the number with adequate imaging, such as a paired size data to evaluate aneurysm growth | | | | | | | | | | | | | | | | ^{2} Eligible for follow-up = eligible for follow-up from the previous interval – (death + withdrawn + lost to follow-up) from the previous interval. All subjects that had an endovascular graft implanted are eligible for follow-up for the operative row. | | | | | | | | | | | | | | | | ^{3} Subjects still within the follow-up window, but data not yet available | | | | | | | | | | | | | | | | ^{4} Computerized tomography (CT) count includes CT and magnetic resonance angiogram (MRA) | | | | | | | | | | | | | | | ### C. Study Population Demographics and Baseline Parameters #### Demographics and Medical History The demographics of the study population are atypical for an AAA endovascular graft study performed in the US due to their relatively poor health status. However, the results apply to all patients who would be eligible for treatment with the devices, including patients with less advanced disease who would be expected to have as good or better outcomes. **Table 3** below provides the demographics and medical history of subjects in the Short Neck cohort, the Very Short Neck Cohort and the On-Label Neck Length Cohort from the ANCHOR Registry. The medical history and the risk factors were noted to be similar across the cohorts. Specifically, in the Short Neck Cohort, the median age of the cohort was 72 years (range: 49 to 95); 72.9% (51/70) of subjects were male and 27.1% (19/70) of subjects were female. The baseline medical history revealed cardiovascular risk factors frequently occurring in the population, including hypertension (84.3% (59/70) of subjects), past or current tobacco use (80.0% (56/70) of subjects), and hyperlipidemia (74.3% (52/70) of subjects); 62.9% (44/70) of subjects were diagnosed with cardiac disease. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 19 {19} Table 4. Baseline Characteristics and Risk Factors | | ANCHOR Short Neck (N = 70) % (m/n)^{1} | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (N = 32) % (m/n)^{1} | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (N = 100) % (m/n)^{1} | | --- | --- | --- | --- | | Age (year) | | | | | n | 70 | 32 | 100 | | Mean ± SD | 71.31 ± 8.13 | 75.66 ± 8.37 | 71.95 ± 8.41 | | Gender %(m/n) | | | | | Male | 72.9% (51/70) | 53.1% (17/32) | 79.0% (79/100) | | Female | 27.1% (19/70) | 46.9% (15/32) | 21.0% (21/100) | | Tobacco Use (past or current) | 80.0% (56/70) | 87.5% (28/32) | 78.0% (78/100) | | Hypertension | 84.3% (59/70) | 87.5% (28/32) | 78.0% (78/100) | | Hyperlipidemia | 74.3% (52/70) | 68.8% (22/32) | 71.0% (71/100) | | Diabetes | 22.9% (16/70) | 12.5% (4/32) | 19.0% (19/100) | | Cardiac disease | | | | | Coronary Artery Disease | 8.6% (6/70) | 12.5% (4/32) | 8.0% (8/100) | | CHF | 7.1% (5/70) | 15.6% (5/32) | 4.0% (4/100) | | Prior MI | 34.3% (24/70) | 28.1% (9/32) | 14.0% (14/100) | | Chronic Obstructive Pulmonary Disease (COPD) | 44.3% (31/70) | 43.8% (14/32) | 27.0% (27/100) | | Renal Disease | | | | | Renal Insufficiency | 11.4% (8/70) | 15.6% (5/32) | 14.0% (14/100) | | Dialysis-Dependent Renal Failure (End-stage renal disease) | 0.0% (0/70) | 0.0% (0/32) | 0.0% (0/100) | | Stroke/Cerebral Vascular Accident | 10.0% (7/70) | 6.3% (2/32) | 9.0% (9/100) | | Bleeding Disorder | 2.9% (2/70) | 6.3% (2/32) | 1.0% (1/100) | | Gastrointestinal Disease | 34.3% (24/70) | 37.5% (12/32) | 39.0% (39/100) | | Peripheral Artery Disease (PAD) | 18.6% (13/70) | 12.5% (4/32) | 11.0% (11/100) | | Thoracic Aneurysm | 2.9% (2/70) | 0.0% (0/32) | 5.0% (5/100) | $^{1}$m = number of subjects in category, n = number of all enrolled subjects with non-missing values. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 20 {20} ### ASA Classification **Table 5** below provides the baseline ASA classification of subjects in the Short Neck cohort, the Very Short Neck Cohort and the On-Label Neck Length Cohort from the ANCHOR Registry. Most subjects enrolled in the Short Neck Cohort were reported to be ASA Class III (67.1%), with severe systemic disease, and a large proportion of the subjects were at high risk of death, with 25.7% (18/70) subjects in ASA Class IV. **Table 5. Baseline ASA Classification** | | ANCHOR Short Neck (N = 70) % (m/n)^{1} | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (N = 32) % (m/n)^{1} | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (N = 100) % (m/n)^{1} | | --- | --- | --- | --- | | **ASA Classification** | | | | | Class I | 2.9% (2/70) | 0.0% (0/32) | 1.0% (1/100) | | Class II | 4.3% (3/70) | 0.0% (0/32) | 13.0% (13/100) | | Class III | 67.1% (47/70) | 65.6% (21/32) | 67.0% (67/100) | | Class IV | 25.7% (18/70) | 34.4% (11/32) | 19.0% (19/100) | $^{1}$m = number of subjects in category, n = number of all enrolled subjects with non-missing values. ### Baseline Parameters The mean core lab-reported neck length (defined as that length over which the aortic diameter remains within 10% of the infrarenal diameter) was 6.86 ± 1.59 mm (range: 4.1 mm to 10.0 mm) for the Short Neck Cohort. Mean site-reported neck length (typically measured from the lowest main renal artery to where the neck visually dilates) was 12.07 ± 5.58 mm (range: 4.0 mm to 33.0 mm). The differences in the core lab vs site-reported neck lengths were likely related to differences in the method of measuring the neck. For the new indication, the core lab methodology should be applied when determining whether EndoAnchors should be used with the endograft. Please see the Physician Instructions for Use for more information. The mean core lab-reported proximal neck diameter was 25.74 ± 4.04 mm (range: 19.0 mm to 36.5 mm) for the Short Neck Cohort. The core lab reported the mean maximum aneurysm diameter as 57.70 ± 12.74 mm (range: 34.1 mm to 112.0 mm). Information regarding the type of lesion treated and the decision to treat (e.g., rapidly growing, twice the normal aortic diameter, >5.5mm) were not captured in the registry. The core lab reported infrarenal angle and suprarenal angle mean as 20.59° (± 14.44) and 14.07° (± 8.28), respectively. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 21 {21} Table 6. Anatomical and Other Measurements (Core Laboratory-Reported) | Measurement | ANCHOR Short Neck (Core laboratory reported) (N = 70) | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (Core laboratory reported) (N = 32) | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (Core laboratory reported) (N = 100) | | --- | --- | --- | --- | | Proximal neck diameter at renal arteries | | | | | n | 70 | 32 | 100 | | Mean ± SD | 25.74 ± 4.04 | 25.55 ± 5.20 | 25.69 ± 4.13 | | Median | 25.90 | 24.85 | 24.75 | | Min, Max | 19.0, 36.5 | 16.9, 35.7 | 17.4, 39.8 | | Proximal Neck Length | | | | | n | 70 | 32 | 100 | | Mean ± SD | 6.86 ± 1.59 | 2.95 ± 0.82 | 22.37 ± 11.82 | | Median | 6.69 | 3.03 | 18.20 | | Min, Max | 4.1, 10.0 | 1.1, 4.0 | 10.0, 62.0 | | Distal Aortic Diameter | | | | | n | 70 | 32 | 100 | | Mean ± SD | 28.80 ± 4.79 | 28.34 ± 5.82 | 27.84 ± 4.53 | | Median | 28.40 | 26.35 | 27.50 | | Min, Max | 19.3, 40.5 | 19.1, 49.3 | 18.4, 43.2 | | Maximum aortic diameter | | | | | n | 69 | 32 | 100 | | Mean ± SD | 57.70 ± 12.74 | 56.46 ± 10.33 | 55.91 ± 11.06 | | Median | 55.00 | 53.70 | 53.05 | | Min, Max | 34.1, 112.0 | 41.7, 92.5 | 28.5, 101.0 | | Suprarenal Angulation | | | | | n | 70 | 32 | 100 | | Mean ± SD | 14.07 ± 8.28 | 13.31 ± 8.71 | 15.70 ± 10.34 | | Median | 12.00 | 13.50 | 14.00 | | Min, Max | 1.0, 38.0 | 2.0, 39.0 | 2.0, 49.0 | | Infrarenal Angulation | | | | | n | 69 | 32 | 100 | | Mean ± SD | 20.59 ± 14.44 | 23.16 ± 15.98 | 26.14 ± 18.55 | | Median | 18.00 | 18.50 | 22.00 | | Min, Max | 2.0, 69.0 | 1.0, 68.0 | 1.0, 80.9 | PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 22 {22} | Measurement | ANCHOR Short Neck (Core laboratory reported) (N = 70) | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (Core laboratory reported) (N = 32) | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (Core laboratory reported) (N = 100) | | --- | --- | --- | --- | | | Neck Thrombus Average Thickness | | | | n | 64 | 29 | 94 | | Mean ± SD | 0.85 ± 1.06 | 1.23 ± 1.42 | 0.89 ± 1.48 | | Median | 0.00 | 1.30 | 0.00 | | Min, Max | 0.0, 3.5 | 0.0, 5.3 | 0.0, 8.9 | | Neck Thrombus Circumference > 1 mm | | | | | n | 64 | 29 | 94 | | Mean ± SD | 61.41 ± 86.33 | 62.94 ± 80.45 | 46.63 ± 72.63 | | Median | 0.00 | 19.60 | 0.00 | | Min, Max | 0.0, 320.0 | 0.0, 298.0 | 0.0, 320.0 | | Neck Calcium Average Thickness | | | | | n | 70 | 32 | 100 | | Mean ± SD | 1.31 ± 1.23 | 1.77 ± 1.28 | 1.03 ± 1.11 | | Median | 1.30 | 1.94 | 1.00 | | Min, Max | 0.0, 4.0 | 0.0, 4.3 | 0.0, 4.6 | | Neck Calcium Circumference > 1 mm | | | | | n | 70 | 32 | 100 | | Mean ± SD | 23.39 ± 29.83 | 38.50 ± 43.62 | 18.26 ± 24.91 | | Median | 16.25 | 20.40 | 10.00 | | Min, Max | 0.0, 155.0 | 0.0, 180.0 | 0.0, 114.0 | ### Device Usage Endurant stent grafts were utilized in 47.1% (33/70) of subjects in the Short Neck Cohort and Endurant II/IIs stent grafts were utilized in 52.9% (37/70) of the subjects. The most frequently used proximal stent graft size in the Short Neck Cohort was 36 mm, which was used in 34.3% (24/70) of subjects. Most subjects were implanted with an Endurant or Endurant II/IIs stent graft with a proximal diameter of 28 mm or larger. The differences in the Endurant, Endurant II and Endurant IIs stent grafts are described in the Annual Physician Clinical Update. All Endurant family aortic stent grafts (Endurant, Endurant II, Endurant IIs) are identical with respect to the design of the proximal end, including the suprarenal stent, anchor pins and sealing zone. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 23 {23} The average number of Heli-FX EndoAnchor implants per subject was 5.49 ± 2.08. The median was 5.0, the minimum was 2.0, and the maximum was 12.0. Table 7 provides detail on stent graft sizing and EndoAnchor usage. Table 7. Endurant Stent Graft Sizing (Proximal Diameter) and Heli-FX EndoAnchor Use | Proximal Size of the Endurant Stent Graft | 23 mm (m/n)% | 25 mm (m/n)% | 28 mm (m/n)% | 32 mm (m/n)% | 36 mm (m/n)% | | --- | --- | --- | --- | --- | --- | | | 7.1% (5/70) | 8.6% (6/70) | 25.7% (18/70) | 24.3% (17/70) | 34.3% (24/70) | | Recommended Number of EndoAnchor Implants^{1} | 4 | 4 | 4 | 4 | 6 | | Number of EndoAnchor Implants Used | | | | | | | 2 | 0.0% (0/5) | 0.0% (0/6) | 5.6% (1/18) | 5.9% (1/17) | 0.0% (0/24) | | 3 | 20.0% (1/5) | 16.7% (1/6) | 0.0% (0/18) | 0.0% (0/17) | 8.3% (2/24) | | 4 | 40.0% (2/5) | 16.7% (1/6) | 44.4% (8/18) | 41.2% (7/17) | 33.3% (8/24) | | 5 | 20.0% (1/5) | 16.7% (1/6) | 11.1% (2/18) | 5.9% (1/17) | 0.0% (0/24) | | 6 | 20.0% (1/5) | 33.3% (2/6) | 27.8% (5/18) | 17.6% (3/17) | 29.2% (7/24) | | > 6 | 0.0% (0/5) | 16.7% (1/6) | 11.1% (2/18) | 29.4% (5/17) | 29.2% (7/24) | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of all enrolled subjects within the Short Neck Cohort with non-missing values. $^{1}$The Heli-FX EndoAnchor System IFU provides a minimum recommended number of EndoAnchor implants based on aortic neck diameter, not device size. The recommended number of EndoAnchor implants used in an aortic neck of ≤ 29 mm is 4, and a minimum of 6 EndoAnchor implants are recommended in an aortic neck >29. The numbers provided in this table are based on the most likely aortic neck diameter for a given device size, based on the Endurant II/IIs Stent Graft System IFU recommended device sizing relative to the aortic vessel inner diameter. In most subjects, a single applier was used, with two SA-85 Heli-FX Appliers used in one subject. The most common Heli-FX guide used was the 22 mm model, which was used in 73.5% (36/49) of the subjects, followed by the 28 mm model, which was used in 26.5% (13/49) of the subjects. See Table 8. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 24 {24} **Table 4. Heli-FX EndoAnchor System Usage** | | Short Neck Cohort (N = 70) | | --- | --- | | Number of Heli-FX Appliers Used | | | n | 49 | | Mean ± SD | 1.02 ± 0.14 | | Median | 1.00 | | Min, Max | 1.0, 2.0 | | Size of Heli-FX Applier(s) Used (m/n)% | | | SA-85 Heli-FX Applier | 98.0% (48/49) | | HA-18-114 Heli-FX Applier | 2.0% (1/49) | | Number of Heli-FX Guides Used | | | n | 49 | | Mean ± SD | 1.04 ± 0.20 | | Median | 1.00 | | Min, Max | 1.0, 2.0 | | Size of Heli-FX Guide(s) Used (m/n)% | | | Heli-FX Guide 22 mm – SG-64 | 73.5% (36/49) | | Heli-FX Guide 22 mm – HG-18-90-22 | 0.0% (0/49) | | Heli-FX Guide 42 mm – HG-18-90-42 | 0.0% (0/49) | | Heli-FX Guide 28 mm – HG-16-62-28 | 26.5% (13/49) | | Heli-FX Guide 32 mm – HG-18-90-32 | 2.0% (1/49) | | Min, Max | 2.0, 12.0 | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of all enrolled subjects within the Short Neck Cohort with non-missing values. ### Accessory Device Usage Twenty-five of 70 subjects in the Short Neck Cohort received at least one accessory device during the index procedure. The type of accessory device used and number of subjects is as follows: Stent (11 subjects), balloon (10 subjects), coil (4 subjects), cuff (3 subjects), vascular plug (2 subjects), and vascular graft (1 subject). Note that subjects may have received more than one accessory device. ### Initial Procedural Data All Short Neck Cohort subjects had EndoAnchors implanted. The mean duration of the procedure was 148.00 ± 80.03 minutes, with average time of EndoAnchor implant of 17.12 ± 11.54 minutes. Mean fluoroscopy time was 35.34 ± 21.98 minutes. See **Table 9** for additional information. The mean overall intensive care unit (ICU) stay was 0.84 ± 1.63 days, and the mean overall hospital stay was 3.73 ± 4.31 days. All Short Neck and on On-Label Neck Cohort subjects had Endurant or Endurant II/IIs stent grafts implanted. In the Very Short Neck Cohort the following stent grafts were used: Cook Zenith 6.3% (2/32), Gore Excluder 25.0% (8/32), Jotec e-Vita 0% (0/32), PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 25 {25} Medtronic AneuRx 0% (0/32), Medtronic Endurant 68.8% (22/32), Medtronic Talent 0% (0/32)$^{3}$. **Table 9. Initial Procedural Data** | Measurement | Short Neck Cohort (N = 70) | | --- | --- | | Type of Procedure (m/n)% | | | Elective | 69.4% (34/49) | | Urgent (investigator assessed) | 22.4% (11/49) | | Emergent (investigator assessed) | 8.2% (4/49) | | Procedure Entry Site^{1} (m/n)% | | | Left Femoral Artery | 82.9% (58/70) | | Right Femoral Artery | 91.4% (64/70) | | Left Iliac Artery | 0.0% (0/70) | | Right Iliac Artery | 0.0% (0/70) | | Left: Other - Brachial percutaneous | 1.4% (1/70) | | Right: Other - Brachial | 1.4% (1/70) | | Type of Access (m/n)% | | | Open | 62.9% (44/70) | | Percutaneous | 37.1% (26/70) | | Duration of implant procedure (min) | | | N | 70 | | Mean ± SD | 148.00 ± 80.03 | | Median | 127.50 | | Min, Max | 38.0, 423.0 | | Type of anesthesia used (m/n)% | | | General | 84.3% (59/70) | | Spinal | 2.9% (2/70) | | Epidural | 1.4% (1/70) | | Local | 11.4% (8/70) | | Volume of contrast (cc) | | | N | 26 | | Mean ± SD | 126.12 ± 80.76 | | Median | 102.50 | | Min, Max | 30.0, 399.0 | | Total fluoroscopic time (mins) | | | N | 44 | | Mean ± SD | 35.34 ± 21.98 | | Median | 30.00 | | Min, Max | 7.0, 123.0 | $^{3}$Devices reported as “other” in the Short Neck, On-Label Neck, and Very Short Neck Cohorts were confirmed to be Endurant devices. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 26 {26} | Measurement | Short Neck Cohort (N = 70) | | --- | --- | | Subjects Receiving EndoAnchor implants (m/n)% | 100.0% (70/70) | | Time to Implant EndoAnchor implants (mins)^{5} | | | N | 68 | | Mean ± SD | 17.12 ± 11.54 | | Median | 13.50 | | Min, Max | 4.0, 60.0 | | Hospital stay (Days)^{2} | | | N | 70 | | Mean ± SD | 3.73 ± 4.31 | | Median | 2.00 | | Min, Max | 1.0, 24.0 | | Procedure stay (Days)^{3} | | | N | 70 | | Mean ± SD | 3.03 ± 3.17 | | Median | 2.00 | | Min, Max | 1.0, 23.0 | | Duration of ICU stay (Days)^{4} | | | N | 69 | | Mean ± SD | 0.84 ± 1.63 | | Median | 0.00 | | Min, Max | 0.0, 11.0 | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of all enrolled subjects within the Short Neck Cohort with non-missing values. $^{1}$Note that more than one procedure entry site per subject may be reported if multiple entry sites were used. $^{2}$Overall hospital stay (days) = Date of Hospital Discharge – Date of Hospital Admission. In the case where Date of Hospital Discharge = Date of Hospital Admission, Overall hospital stay will be considered to be 0.5 day $^{3}$Procedural hospital stay (days) = Date of Hospital Discharge – Date of Initial Procedure. In the case where Date of Hospital Discharge = Date of Initial Procedure, procedural hospital stay will be considered to be 0.5 day $^{4}$ICU stay: days collected as 0, 1, 2...10 days or 10+days. 10+days set to 11 days for summary statistics $^{5}$ EndoAnchor total implant time includes all EndoAnchor implants for one subject ## Procedure-Related Supportive Outcomes ### *Index Procedure-Related Measures for the Short Neck Cohort* Index procedure-related measures include procedure time, fluoroscopy time, procedure success and accessory devices used (and relation, if any, to device or procedure-related events). PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 27 {27} ### Procedure Success Procedure success was reported by investigators and was not prospectively defined. Investigators reported an overall procedure success of 97.1% (68/70); unsuccessful procedures were reported in one subject due to failure to deliver the main body endograft to the intended landing zone and in another subject due to a persistent Type Ia endoleak. There were no main body endograft components that were misdeployed proximally to the intended landing zone. Type Ia endoleak was reported as present at the end of the procedure in 12.9% (9/70) of subjects. There were no Type III endoleaks reported as present at the end of the procedure. See the **Primary Outcomes** section below for further information. ### Accessory Devices Twenty-five of 70 subjects in the Short Neck Cohort received at least one accessory device during the index procedure. A majority of accessory devices were placed in subjects without reported AEs on the day of index procedure. Reasons for accessory device usage were not documented. See Device Usage section (above) for additional detail. ## D. Safety and Effectiveness Results ### 1. Safety Results There was not a Primary Outcome analysis for safety. It should be noted that the safety of the Endurant II/IIs Stent Graft System for the treatment of infrarenal abdominal aortic aneurysms having neck lengths $\geq 4$ mm and $< 10$ mm ('short necks'), when used in conjunction with the Heli-FX EndoAnchor System was not based on this study alone, but rather on data from the entire ANCHOR Registry (summarized below), the prior EndoAnchor study (summarized in the Instructions for Use of the Heli-FX EndoAnchor System), and the prior Endurant studies (summarized in the Annual Physician Clinical Update for the Endurant/Endurant II/Endurant IIs Stent Graft Systems). ### Supportive Outcomes The analysis of safety was based on the Short Neck Cohort of 70 patients available for the 1-month evaluation and 66 patients available for the 12-month evaluation. The key safety outcomes for this study are presented below in **Table 10** through **Table 5**. Adverse effects are reported in **Table 6** through **Table 7**. #### *Safety-related measures* Safety-related measures presented here include aneurysm-related mortality through 30 days and 12 months, aneurysm rupture through 30 days and 12 months, major adverse events through 30 days, renal insufficiency through 30 days, and renal failure through 30 days. Results for the Very Short Neck Cohort and the On-Label Neck Cohort are included to provide context for the Short Neck Cohort results. Aneurysm-related mortality is defined as any death within 30 days of the index procedure or secondary procedure to address aneurysm, or death from any rupture. Four of 70 subjects (5.7%) died within 30 days of the index procedure. It is important to note that the adverse events leading to death were assessed by the investigator, and no events were noted as related to the aneurysm. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 28 {28} PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 29 {29} **Table 8. Summary of Aneurysm-related Deaths through 12 Months** | Subject Number | Days to Death | Death within 30 days of the initial procedure | Death within 30 days of a re-intervention | Cause of Death (Investigator Determined) | | --- | --- | --- | --- | --- | | 172-014 | 6 | Yes | No | Cardiac arrest, congestive heart failure | | 109-009 | 9 | Yes | No | Cardiac and Respiratory Arrest | | 172-026 | 5 | Yes | No | Cardiac Arrest | | 109-031 | 13 | Yes | No | Acute Alcoholic Hepatitis, Acute Renal Failure, Acute Pancreatitis | Based on number of all enrolled subjects within the Short Neck Cohort with available data. **Table 9** Error! Reference source not found. summarizes a number of safety-related measures that were identified as Supportive Outcomes in the analysis of the Short Neck Cohort. Of note, 5.7% (4/70) of Short Neck Cohort subjects died within one month of the index procedure, which by definition classifies them as aneurysm-related regardless of the cause of death determined by the investigator. See **Table 10** above for further detail. No subjects experienced aneurysm rupture through one year. As will be discussed below, 15.7% (11/70) of Short Neck Cohort subjects experienced at least one major adverse event through one month. One subject experienced renal insufficiency within 30 days of the index procedure. No renal failure was reported by sites through one month; however, one subject with a history of renal insufficiency died on Day 13, and the investigator-determined cause of death included renal failure. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 30 {30} **Table 10. Summary of Safety-Related Measures** | Safety-related measures | ANCHOR Short Neck (N = 70) | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (N = 32) | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (N = 100) | | --- | --- | --- | --- | | Aneurysm-related mortality through 30 days^{1} | 5.7% (4/70) | 6.3% (2/32) | 0.0% (0/100) | | Aneurysm-related mortality through 12 months^{1} | 5.9% (4/68) | 7.1% (2/28) | 0.0% (0/91) | | Aneurysm rupture through 30 days | 0.0% (0/70) | 0.0% (0/32) | 0.0% (0/100) | | Aneurysm rupture through 12 months | 0.0% (0/64) | 0.0% (0/26) | 0.0% (0/91) | | Major adverse events through 30 days | 15.7% (11/70) | 9.4% (3/32) | 4.0% (4/100) | | Renal insufficiency through 30 days^{2} | 0.0% (0/70)^{5} | 6.3% (2/32) | 0.0% (0/100) | | Renal failure through 30 days^{3} | 0.0% (0/70)^{4} | 0.0% (0/32) | 0.0% (0/100) | m = number of subjects in category, n = number of subjects with available imaging assessments for aneurysm expansion and migration and endoleak at 12 months, and number of subjects who had an event in question or reached the lower time window of the time period for site-reported events. $^{1}$Aneurysm-related mortality is defined as death within 30 days of the index procedure, death within 30 days of any secondary procedure to address the aneurysm, or death from rupture. $^{2}$A rise in creatinine greater than 50% above the pre-procedure level resulting in a creatinine level above the upper limit of normal (site reported) $^{3}$Defined as when the need for dialysis is required, an increase in serum creatinine of 2x the baseline value or new need for hemodialysis (site reported) $^{4}$Subject 109-031 died on Day 13 post-index procedure and the investigator-determined cause of death included acute renal failure. Acute renal failure was captured under multi-system organ failure in **Table 14**. $^{5}$Subject 138-012 experienced renal insufficiency through 30 days from the index procedure. The site entered the start date of this event as a partial date of March 2014 in the database. Due to the partial date entry, the days from index for this event was imputed per the statistical analysis plan. The imputation of this event resulted in the event populating at -2 days from index procedure. Although the exact start date is unknown, it is known that the event occurred within the same month of the index procedure. The renal insufficiency category in this table captures events between Day 0-30. Due to this, the renal insufficiency event for this subject at -2 days is not populating in this table. ### *Additional Outcomes* Key additional safety outcomes that are reported in relation to AAA studies were included to provide a broader view of the clinical results. The additional outcomes presented here include all-cause mortality, major adverse events through 12 months and serious adverse events through 12 months. **All-Cause Mortality:** Of the 70 subjects in the Short Neck Cohort, five died within the first 12 months of the index procedure. No subjects died on the day of the index procedure. Four of 70 subjects (5.7%) died within the 30 days of the index procedure and these deaths were therefore determined to be aneurysm-related. One additional subject died on Day 353 post-index procedure due to septic shock secondary to pneumonia/ PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 31 {31} septicemia. This event was not determined to be related to the aneurysm, device, or index procedure. Kaplan-Meier survival estimates for all-cause mortality (ACM) were made through 365 days post-implant as shown in **Table 11** and Figure 7. The Kaplan-Meier one-year survival estimate for ACM was 92.6%. **Table 12. Kaplan-Meier Estimates for All-Cause Mortality – Short Neck Cohort Subjects** | | Day 0 | Day 30 | Day 182 | Day 365 | | --- | --- | --- | --- | --- | | No. at Risk^{1} | 70 | 66 | 61 | 53 | | No. of Events | 0 | 4 | 4 | 5 | | No. Censored^{2} | 0 | 0 | 5 | 12 | | Kaplan-Meier Estimate^{3} | 1.000 | 0.943 | 0.943 | 0.926 | | Peto Standard Error | 0.000 | 0.028 | 0.028 | 0.034 | $^{1}$Number of subjects at risk at each timepoint. Based on number of all enrolled subjects within the Short Neck Cohort with available data. $^{2}$Subjects are censored because no event was observed by the time point, including those not yet reached the correspondent time point or lost to follow-up. $^{3}$Estimate made at each timepoint. Note: All numbers except standard errors are cumulative. ![img-10.jpeg](img-10.jpeg) **Figure 7. Freedom from All-Cause Mortality** PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 32 {32} **Major Adverse Events through 12 Months:** A total of 18 MAEs were reported among 15 subjects between 0 and 365 days. Among those, 13 MAEs were reported in 11 subjects between 0 and 30 days, and five MAEs were reported in five subjects between 31 and 365 days. Three subjects had more than one MAE within the first year. There were no reports of paraplegia, or renal failure through 12 months. However, as mentioned previously, one subject with a history of renal insufficiency died on Day 13 post-index procedure and the investigator-determined cause of death included acute renal failure. **Table 13** summarizes the major adverse events through 12 months. **Table 14. Major Adverse Events (MAEs) through 12 months** | Event | 0-30 Days % (m/n) | 31-365 Days % (m/n) | 0-365 Days % (m/n) | | --- | --- | --- | --- | | One or more major adverse events (MAE) | 15.7% (11/70) | 7.6% (5/66) | 21.4% (15/70) | | Total Number of MAEs | 13 | 5 | 18 | | All-Cause Mortality | 5.7% (4/70) | 1.5% (1/66) | 7.1% (5/70) | | Bowel ischemia | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Myocardial infarction | 2.9% (2/70) | 1.5% (1/66) | 2.9% (2/70) | | Paraplegia | 0.0% (0/70) | 0.0% (0/66) | 0.0% (0/70) | | Procedural blood loss^{1} | 7.1% (5/70) | 0.0% (0/66) | 7.1% (5/70) | | Renal failure | 0.0% (0/70)^{2} | 0.0% (0/66) | 0.0% (0/70)^{2} | | Respiratory failure | 1.4% (1/70) | 3.0% (2/66) | 4.3% (3/70) | | Stroke | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of subjects are at risk at the beginning of the time period. $^{1}$Volume of blood loss was not collected, therefore, procedural blood loss/hemorrhage reported as an SAE at the time of the index procedure or secondary procedure has been reported as an MAE $^{2}$ Subject 109-031 died on Day 13 post-index procedure and the investigator-determined cause of death included acute renal failure. Acute renal failure was captured under multi-system organ failure in **Table 15**. **Serious Adverse Events through 12 Months:** Thirty of 70 subjects (42.9%) experienced one or more serious adverse event between 0 and 365 days. Sixteen (16) of 70 subjects (22.9%) experienced one or more serious adverse event between 0 and 30 days, and 19 out of 66 subjects (28.8%) experienced one or more serious adverse event between 31 and 365 days. The most common type of SAEs were cardiac disorders, reported in 9 out of 70 subjects (12.9%). The second most common type of SAEs were vascular disorders and gastrointestinal disorders, reported in 7 out of 70 subjects (10.0%). Error! Reference source not found. summarizes the subjects with serious adverse events by date of onset. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 33 {33} **Table 14. Serious Adverse Events (SAEs) through 12 months** | Category | 0 to 30 Days % (m/n) | 31 to 365 Days % (m/n) | 0 to 365 Days % (m/n) | | --- | --- | --- | --- | | **Number of Subjects Eligible for each follow-up window** | 70 | 66 | 70 | | **Subjects Experiencing One or More SAEs^{1}** | 22.9% (16/70) | 28.8% (19/66) | 42.9% (30/70) | | **Blood and lymphatic system disorders** | 2.9% (2/70) | 1.5% (1/66) | 4.3% (3/70) | | Anemia | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Anemia postoperative | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Neutropenic fever | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Cardiac disorders** | 7.1% (5/70) | 7.6% (5/66) | 12.9% (9/70) | | Arrhythmia | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Cardiac arrest | 2.9% (2/70) | 0.0% (0/66) | 2.9% (2/70) | | Congestive cardiac failure aggravated | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Congestive heart failure | 0.0% (0/70) | 4.5% (3/66) | 4.3% (3/70) | | Coronary artery disease aggravated | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Myocardial infarction | 2.9% (2/70) | 1.5% (1/66) | 2.9% (2/70) | | Ventricular tachycardia | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Gastrointestinal disorders** | 2.9% (2/70) | 7.6% (5/66) | 10.0% (7/70) | | Diverticulitis | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | GI bleed | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Hernia inguinal | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Ischemic colitis | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Pancreatic cancer | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Retroperitoneal hematoma | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Retroperitoneal mass | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **General disorders and administration site conditions** | 4.3% (3/70) | 0.0% (0/66) | 4.3% (3/70) | | Device occlusion | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Multi organ failure | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Stent-graft endoleak | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | **Infections and infestations** | 1.4% (1/70) | 6.1% (4/66) | 7.1% (5/70) | | Bronchitis | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Pneumonia | 0.0% (0/70) | 3.0% (2/66) | 2.9% (2/70) | | Sepsis | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Septicaemia | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Urinary tract infection | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Injury, poisoning and procedural complications** | 4.3% (3/70) | 1.5% (1/66) | 5.7% (4/70) | | Femoral artery injury | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Post procedural bleeding | 2.9% (2/70) | 0.0% (0/66) | 2.9% (2/70) | | Procedural bleeding | 2.9% (2/70) | 0.0% (0/66) | 2.9% (2/70) | | Scalp laceration | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Vascular access site bleeding | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | **Metabolism and nutrition disorders** | 1.4% (1/70) | 3.0% (2/66) | 4.3% (3/70) | | Respiratory failure | 1.4% (1/70) | 3.0% (2/66) | 4.3% (3/70) | PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 34 {34} | Category | 0 to 30 Days % (m/n) | 31 to 365 Days % (m/n) | 0 to 365 Days % (m/n) | | --- | --- | --- | --- | | **Neoplasms benign, malignant and unspecified (including cysts and polyps)** | 0.0% (0/70) | 3.0% (2/66) | 2.9% (2/70) | | Bladder cancer recurrent | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Hepatic cancer | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Nervous system disorders** | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Subarachnoid hemorrhage | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Psychiatric disorders** | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Mental status changes | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | **Renal and urinary disorders** | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Renal insufficiency | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Respiratory, thoracic and mediastinal disorders** | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | COPD exacerbation | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Skin and subcutaneous tissue disorders** | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Lower extremities ulcers of | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | **Vascular disorders** | 5.7% (4/70) | 6.1% (4/66) | 10.0% (7/70) | | Aneurysm | 1.4% (1/70) | 1.5% (1/66) | 2.9% (2/70) | | Deep vein thrombosis | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Hypertension | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Peripheral artery dissection | 0.0% (0/70) | 1.5% (1/66) | 1.4% (1/70) | | Peripheral ischemia | 1.4% (1/70) | 1.5% (1/66) | 2.9% (2/70) | | Thrombosis | 1.4% (1/70) | 1.5% (1/66) | 2.9% (2/70) | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects experiencing one or more serious adverse events in a category, n = number of subjects at risk at the beginning of the time period. $^{1}$A subject may report multiple adverse events and in different subcategories; hence, number of subjects in each category may not be the sum of those in each subcategory. Each subject was only counted once in each subcategory and category. Investigators were asked to assess relatedness of reported SAEs to device, index or re-intervention procedure, or AAA disease, the results of which are shown in **Table 16**. All events determined to be related to device, procedure, or AAA occurred within 30 days of the index procedure, many of which occurred on the day of the index procedure. There were no re-intervention-related SAEs or unanticipated adverse device effects (UADEs) reported through 365 days. Of the events determined to be related to device, index or re-intervention procedure or AAA disease, SAEs were most commonly reported to be index procedure-related. Nine out of 70 subjects (12.9%) were reported to have an index procedure-related SAE between 0 and 30 days; three subjects experienced these on the day of the index procedure. The most common reasons for index procedure-related SAEs were procedural bleed and anemia. Two out of 70 subjects (2.9%) were reported to have an AAA-related SAE between 0 and 30 days, both occurred on Day 0. One subject experienced a femoral artery injury and bleeding at the vascular access site. The other subject experienced post-procedural bleeding. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 35 {35} There were two device-related adverse events through 12 months. Subject 178-013 was hospitalized for device occlusion on Day 18 post-index procedure. The subject underwent an emergent, endovascular thrombectomy entirely within the endograft. Subject 162-002 experienced peripheral ischemia with bilateral claudication on Day 59 post-index procedure. The subject was treated with medication and the AE remained continuing with treatment as of the date of this summary. **Table 175. Device-Related Adverse Events through 12 months** | Subject Number | Event Type (AE/SAE) | Related to Endograft, Heli-FX, or Both | Study Day | AE Term^{1} | | --- | --- | --- | --- | --- | | 178-013 | SAE | Related to Endograft | 18 | Device occlusion | | 162-002 | AE | Related to Endograft | 59 | Peripheral ischemia | Based on number of all enrolled subjects within the Short Neck Cohort with available data. $^{1}$Subjects may appear on this table more than one time if they experienced more than one device related event. **Table 18: Relatedness of Serious Adverse Events through 12 Months** | | 0-30 Days % (m/n) | 31-365 Days % (m/n) | 0-365 Days % (m/n) | | --- | --- | --- | --- | | Index procedure related SAEs | 12.9% (9/70) | 0.0% (0/66) | 12.9% (9/70) | | Re-intervention related SAEs | 0.0% (0/70) | 0.0% (0/66) | 0.0% (0/70) | | AAA-related SAEs | 2.9% (2/70) | 0.0% (0/66) | 2.9% (2/70) | | Device related SAE | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Related to Endograft | 1.4% (1/70) | 0.0% (0/66) | 1.4% (1/70) | | Related to Heli-FX | 0.0% (0/70) | 0.0% (0/66) | 0.0% (0/70) | | Related to both | 0.0% (0/70) | 0.0% (0/66) | 0.0% (0/70) | | UADEs | 0.0% (0/70) | 0.0% (0/66) | 0.0% (0/70) | Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of subjects who are at risk at beginning of the time period. ## 2. Effectiveness Results The analysis of effectiveness was based on the Short Neck Cohort of 70 patients available for the 1-month evaluation and 66 patients available for the 12-month evaluation. Key effectiveness outcomes are presented in **Table 19** through **Table 21**. ### Primary Outcomes The primary effectiveness outcomes were technical success rate, Type Ia endoleak rate at 1 month and 12 months and reintervention rate through 12 months. A summary of primary outcomes for the ANCHOR Short Neck Cohort, ANCHOR Very Short Neck Cohort and ANCHOR On-Label Neck Cohort is provided in **Table 20**, below. The impact of the number of EndoAnchors used on primary outcomes is discussed below and is summarized in the **Supportive Outcomes** section, **Table 19**. PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 36 {36} **Table 21. Summary of Primary Outcomes** | Event | ANCHOR Short Neck (N = 70) | 95% Confidence Interval | ANCHOR supportive cohort: Very Short Neck < 4 mm (all stent grafts) (N = 32) | ANCHOR supportive cohort: On-Label Neck ≥ 10 mm (Endurant) (N = 100) | | --- | --- | --- | --- | --- | | Type Ia Endoleak at 1-month^{1} | 6.8% (4/59) | [1.9%, 16.5%] | 16.0% (4/25) | 0.0% (0/91) | | Type Ia Endoleak at 1-year^{1} | 1.9% (1/53) | [0.0%, 10.1%] | 0.0% (0/20) | 0.0% (0/73) | | Secondary Procedures through 1 year | 4.7% (3/64) | [1.0%, 13.1%] | 7.7% (2/26) | 2.2% (2/91) | | Secondary Endovascular Procedures through 1 year | 4.7% (3/64) | [1.0%, 13.1%] | 7.7% (2/26) | 2.2% (2/91) | | Conversion to Open Surgical Repair through 1 year | 0.0% (0/64) | [0.0%, 5.6%] | 0.0% (0/26) | 0.0% (0/91) | | Other Secondary Open Surgical Procedures through 1 year | 1.6% (1/64) | [0.0%, 8.4%] | 0.0% (0/26) | 0.0% (0/91) | | Technical Success Rate at Index Procedure^{2}: | 88.6% (62/70) | [78.7%, 94.9%] | 84.4% (27/32) | 94.9% (94/99) | | Successful delivery: | | | | | | Access to the targeted aortic site was achieved by the EndoAnchor system | 100.0% (70/70) | [94.9%, 100.0%] | 100.0% (32/32) | 100.0% (100/100) | | Successful delivery of the main body to the intended landing zone | 94.3% (66/70) | [86.0%, 98.4%] | 96.9% (31/32) | 99.0% (99/100) | | Successful and accurate deployment of the Endurant II/IIs stent graft and the Aptus Heli-FX EndoAnchor System | | | | | | Successful deployment of the endovascular stent graft at the intended implantation site^{3} | 100.0% (70/70) | [94.9%, 100.0%] | 100.0% (32/32) | 98.0% (97/99) | | Successful and accurate deployment of EndoAnchor implants was achieved^{4} | 92.9% (65/70) | [84.1%, 97.6%] | 87.5% (28/32) | 96.0% (96/100) | | Absence of unintentional coverage of the renal arteries | 97.1% (68/70) | [90.1%, 99.7%] | 96.9% (31/32) | 100.0% (100/100) | PMA P100021/S063: FDA Summary of Safety and Effectiveness Data Page 37 {37} Based on number of all enrolled subjects within the Short Neck Cohort with available data. m = number of subjects in category, n = number of subjects with available values. For secondary procedures through 1 year, the denominator includes subjects who had an event or had been followed for at least 184 days. ¹Core laboratory reported ²Technical success was defined as: successful delivery and deployment of the stent graft, without unintentional coverage of the renal arteries, and successful implantation of the EndoAnchor implants at the target aortic site. ³Absence o…
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