Zenith Dissection Endovascular System

P180001 · William Cook Europe Aps · MIH · Dec 31, 2018 · Cardiovascular

Device Facts

Record IDP180001
Device NameZenith Dissection Endovascular System
ApplicantWilliam Cook Europe Aps
Product CodeMIH · Cardiovascular
Decision DateDec 31, 2018
DecisionAPPR
Device ClassClass 3
AttributesTherapeutic, Real-World Evidence

Real-World Evidence

SubmissionDeviceSponsorRWD SourcesRWE Use SummaryKey Tags
P180001 · Dec 31, 2018Zenith Dissection Endovascular SystemWilliam Cook Europe ApsSociety for Vascular Surgery (SVS) Outcomes Committee dataset; SVS Vascular Quality Initiative (VQI) registryThe SVS dataset was used to establish performance goals for the primary clinical study (30-day survival and freedom from major adverse events). The SVS VQI registry is mandated for post-market surveillance.Performance goal derivation; Registry-based surveillance; SVS dataset; VQI

Clinical Evidence

Study DesignPopulationComparatorKey Endpoints
SVS Outcomes Committee dataset; Pooled retrospective clinical dataPatients with acute, complicated Type B aortic dissection; Sample Size: 85; Number of Sites: Multiple (pooled)Not applicable for this study30-day survival rate, freedom from Major Adverse Events (MAEs) at 30 days

Indications for Use

The Zenith® Dissection Endovascular System (Zenith® TX2® Dissection Endovascular Graft with Pro-Form and Zenith® Dissection Endovascular Stent) is indicated for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal entry tears and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having vascular anatomy suitable for endovascular repair, including: - Adequate iliac/femoral access compatible with the required introduction systems, - For the Zenith TX2 Dissection Endovascular Graft with Pro-Form: - Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm, - Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm, and - For the Zenith Dissection Endovascular Stent: - Diameter at non-aneurysmal intended implant site (measured outer-wall to outer-wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter).

Device Story

System treats Type B aortic dissection; consists of Zenith TX2 Dissection Endovascular Graft (stent-graft) and Zenith Dissection Endovascular Stent (bare stent). Graft seals entry tears; excludes aneurysms in chronic dissections. Bare stent provides distal support to delaminated non-aneurysmal aortic segments. Used in OR/clinic by vascular surgeons; delivered via Z-Trak Plus Introduction System (16-22 Fr) over .035 inch wire guide. Stent-graft uses trigger-wire release; bare stent uses trigger-wire release with anti-torque brace. Fluoroscopic visualization via gold radiopaque markers. Output is physical exclusion of dissection/aneurysm; stabilizes aortic lumen; promotes favorable remodeling. Benefits include avoiding open surgical repair; reducing mortality/morbidity associated with untreated dissection.

Clinical Evidence

Prospective, non-randomized, single-arm, multi-center pivotal study (n=73). Primary endpoints: 30-day survival (95.5%, met 79.4% goal, p<0.001) and 30-day freedom from Major Adverse Events (71.6%, met 51.2% goal, p<0.001). Secondary endpoints included aortic diameter changes, false lumen thrombosis, and device integrity. Core lab imaging confirmed favorable remodeling (true lumen expansion, false lumen reduction). No stent fractures observed through 12 months.

Technological Characteristics

Stent-graft: Woven polyester fabric, stainless steel Cook-Z stents, polyester/polypropylene sutures. Bare stent: Nitinol Cook-Z segments, polyester sutures. Delivery: Z-Trak Plus system (16-22 Fr), hydrophilic coating, trigger-wire release. Radiopaque gold markers. Sterilization: Standardized processes leveraged from Zenith family. Connectivity: None (mechanical).

Indications for Use

Indicated for endovascular treatment of Type B aortic dissection in patients with suitable vascular anatomy. Contraindicated in patients with sensitivities to stainless steel, polyester, polypropylene, nitinol, or gold, and patients with systemic infection.

Predicate Devices

Reference Devices

Submission Summary (Full Text)

{0} SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. GENERAL INFORMATION Device Generic Name: Endovascular Graft and Stent Device Trade Name: Zenith® Dissection Endovascular System Device Procode: MIH Applicant's Name and Address: William Cook Europe ApS Sandet 6, DK 4632 Bjaeverskov, Denmark Date of Panel Recommendation: None Premarket Approval (PMA) Application Number: P180001 Date of FDA's Notice of Approval: 12/31/2018 The Zenith® Dissection Endovascular System consists of a stent-graft component (Zenith® TX2® Dissection Endovascular Graft with Pro-Form®) and bare stent component (Zenith® Dissection Endovascular Stent). The bare stent component (intended for a subset of the patients covered by the indications for use) is unique to the Zenith Dissection Endovascular System, whereas the stent-graft component (intended for all patients covered by the indications for use) is a line extension to Cook's Zenith® TX2® TAA Endovascular Graft (P070016). The Zenith TX2 TAA Endovascular Graft was approved for the treatment of patients with aneurysms or ulcers of the descending thoracic aorta. The Summary of Safety and Effectiveness Data (SSED) for the Zenith TX2 TAA Endovascular Graft is available on the CDRH website and is incorporated by reference here (http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070016B.pdf). This PMA builds on the knowledge gained with the Zenith® TX2® TAA Endovascular Graft. II. INDICATIONS FOR USE The Zenith® Dissection Endovascular System (Zenith® TX2® Dissection Endovascular Graft with Pro-Form and Zenith® Dissection Endovascular Stent) is indicated for the endovascular treatment of patients with Type B aortic dissection. The Zenith TX2 Dissection Endovascular Graft with Pro-Form is intended to seal entry tears and to exclude aneurysms associated with chronic dissections. The Zenith Dissection Endovascular Stent is intended to be used as a distal component to provide support to delaminated segments of non-aneurysmal aorta with dissection distal to a Zenith TX2 PMA P180001: FDA Summary of Safety and Effectiveness Data {1} Dissection Endovascular Graft with Pro-Form. The system is indicated for use in patients having vascular anatomy suitable for endovascular repair, including: - Adequate iliac/femoral access compatible with the required introduction systems, - For the Zenith TX2 Dissection Endovascular Graft with Pro-Form: - Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a length of at least 20 mm, - Non-dissected/aneurysmal aortic segments (fixation sites) distal to the left common carotid artery and proximal to the entry tear with a diameter (measured outer-wall to outer-wall) of no greater than 38 mm and no less than 20 mm, and - For the Zenith Dissection Endovascular Stent: - Diameter at non-aneurysmal intended implant site (measured outer-wall to outer-wall) of no greater than 38 mm (true lumen) and no less than 20 mm (total aortic diameter). ## III. CONTRAINDICATIONS The Zenith® Dissection Endovascular System is contraindicated in: - Patients with known sensitivities or allergies to stainless steel, polyester, polypropylene, nitinol or gold. - Patients with a systemic infection who may be at increased risk of endovascular graft/stent infection. ## IV. WARNINGS AND PRECAUTIONS The warnings and precautions can be found in the Zenith® Dissection Endovascular System labeling (Instructions for Use). ## V. DEVICE DESCRIPTION The Zenith® Dissection Endovascular System consists of the Zenith® TX2® Dissection Endovascular Graft with Pro-Form® (stent-graft component) and the Zenith® Dissection Endovascular Stent (bare stent component), as shown in Figure 1. PMA P180001: FDA Summary of Safety and Effectiveness Data Page 2 {2} ![img-0.jpeg](img-0.jpeg) Figure 1. Zenith® Dissection Endovascular System consisting of the Zenith® TX2® Dissection Endovascular Graft with Pro-Form® (stent-graft component) and the Zenith® Dissection Endovascular Stent (bare stent component) # A. Zenith® TX2® Dissection Endovascular Graft with Pro-Form® The stent-graft component of the Zenith® Dissection Endovascular System is the Zenith® TX2® Dissection Endovascular Graft with Pro-Form® (also referred to as the Dissection Endovascular Graft). It is a one-piece tubular endovascular graft (Figure 2) that is intended to seal entry tears and to exclude aneurysms associated with chronic dissections. The graft is constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel Cook-Z® stents with braided polyester and monofilament polypropylene sutures. The graft is available in a straight or tapered configuration, both of which are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. Additionally, the Cook-Z® stents provide the necessary attachment and seal of the graft to the vessel wall without the use of barbs. The proximal and distal ends of the stent-graft have an internal sealing stent. To facilitate fluoroscopic visualization of the stent-graft, four gold radiopaque markers are positioned at each end of the graft. These markers are placed in a circumferential orientation within $1\mathrm{mm}$ of the most proximal and distal aspects of the graft material. The graft is available in diameters ranging from $22\mathrm{mm}$ to $42\mathrm{mm}$ , including non-tapered and tapered ( $4\mathrm{mm}$ and $8\mathrm{mm}$ tapered) configurations. There are multiple lengths available for each graft diameter, ranging from 79 to $218\mathrm{mm}$ . The Zenith Dissection Endovascular Graft with Pro-Form is loaded onto the Zenith TX2 Dissection Endovascular Graft Z-Trak Plus Introduction System. Pro-Form refers to the attachment with trigger-wires of both ends of the proximal seal stent to the introduction system. PMA P180001: FDA Summary of Safety and Effectiveness Data {3} ![img-1.jpeg](img-1.jpeg) Figure 2. Zenith® TX2® Dissection Endovascular Graft with Pro-Form® shown in a straight configuration # B. Zenith® TX2® Dissection Endovascular Graft Z-Trak Plus® Introduction System Figure 3 illustrates the Zenith® TX2® Dissection Endovascular Graft Z-Trak Plus® Introduction System (20 Fr or 22 Fr). The Zenith TX2 Dissection Endovascular Graft Z-Trak Plus Introduction System has a single trigger-wire release mechanism to secure the endovascular graft onto the introduction system until released by the user. The introduction system is compatible with a .035 inch wire guide and uses the Captor® Hemostatic Valve and Flexor® introducer sheath. There is a hydrophilic coating on the sheath and tip. ![img-2.jpeg](img-2.jpeg) Figure 3. Zenith® TX2® Dissection Endovascular Graft Z-Trak Plus® Introduction System # C. Zenith® Dissection Endovascular Stent The bare stent component of the Zenith® Dissection Endovascular System is the Zenith® Dissection Endovascular Stent (also referred to as the Dissection Stent). The Dissection Stent is a one-piece tubular device with a slight flare in the stent at its proximal end, constructed from self-expanding nitinol Cook-Z® stent segments sewn together with polyester suture (Figure 4). The Dissection Stent is used as a distal component in combination with the Dissection Endovascular Graft. No graft material is used in this component in order to avoid coverage of spinal and visceral branch vessels. The Dissection Stent is available in 2 diameters (36 mm and 46 mm), which come in multiple lengths. The 36mm diameter Dissection Stent is available in 80mm, 120mm, and 180mm lengths, and the 46mm Dissection Stent is available in 80mm, 120mm, and 185mm PMA P180001: FDA Summary of Safety and Effectiveness Data {4} lengths. There are gold radiopaque markers at the proximal and distal ends to facilitate fluoroscopic visualization. ![img-3.jpeg](img-3.jpeg) Figure 4. Zenith® Dissection Endovascular Stent # D. Zenith® Dissection Endovascular Stent Z-Trak Plus® Introduction System The Dissection Stent is shipped preloaded in a 16 Fr Z-Trak Plus® Introduction System (Figure 5), which uses a single trigger-wire release mechanism to secure the endovascular stent onto the introduction system until released by the physician. The introduction system is compatible with a .035 inch wire guide and uses the Captor® Hemostatic Valve and Flexor® introducer sheath. In addition, there is an anti-torque brace at the user interface (adjacent to the valve) to maintain rotational alignment of the sheath relative to the central carrier to which the stent component is attached. There is a hydrophilic coating on the sheath and tip. ![img-4.jpeg](img-4.jpeg) Figure 5. Zenith® Dissection Endovascular Stent 16 Fr Z-Trak Plus® Introduction System # E. Comparison between the Zenith Dissection Endovascular System and Other Endovascular Devices in the Zenith Family The Zenith Dissection Endovascular System is a line extension to the Zenith family of endovascular devices. The Dissection Endovascular Graft is nearly identical to the Zenith TX2 TAA Endovascular Graft, which was approved for the treatment of patients with aneurysms or ulcers of the descending thoracic aorta (P070016). The only differences are that the Dissection Endovascular Graft does not have barbs and includes a greater range of stent graft sizes (shorter and longer lengths, smaller diameters, and increased stent graft taper offered). PMA P180001: FDA Summary of Safety and Effectiveness Data {5} The Dissection Stent is unique in that it does not include a covering material, but is otherwise very similar to the Zenith Alpha Thoracic Endovascular Graft, which was approved for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta (P140016), utilizing the same materials, vendor, manufacturing processes, and sterilization. The introduction systems for the Dissection Endovascular Graft and Dissection Stent are based on the Zenith TX2 TAA Endovascular Graft's Z-Trak Plus Introduction System with a few updates to align with more recently approved Zenith Endovascular Grafts and accommodate the Dissection Endovascular Graft and Dissection Stent. The main differences include an increased sheath length for both systems, a smaller sheath size for the bare stent system only, updated ergonomics on the hemostasis valve and knobs on the peel away sheath, the addition of an anti-torque brace for the bare stent system only, and use of a different hydrophilic coating (same as used on the commercially available Zenith Spiral-Z Iliac Leg Graft, approved under P020018/S037). For additional details on the Zenith Dissection Endovascular System, refer to the Instructions for Use. ## VI. ALTERNATIVE PRACTICES AND PROCEDURES There are several alternatives for treatment of Type B aortic dissection, including: endovascular repair with another stent-graft device, open surgical repair involving implantation of a synthetic graft within the dissected vessel, and medical management. Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle. ## VII. MARKETING HISTORY The Dissection Endovascular Graft and Dissection Stent are commercially available in the following countries and have not been withdrawn from any market for any reason: Afghanistan, Albania, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Austria, Australia, Azerbaijan, Bahamas, Bahrain, Barbados, Belgium, Belize, Benin, Bermuda, Bhutan, Botswana, Bouvet Island, Brazil, British Indian Ocean, Brunei, Bulgaria, Burkina Faso, Burundi, Cameroon, Canary Island, Cape Verde, Cayman Islands, Central African Republic, Chad, Chile, Christmas Island, Cocos Island, Colombia, Comoros, Congo, Cook Islands, Costa Rica, Côte d'Ivoire, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Egypt, El Salvador (graft only), Equatorial Guinea, Eritrea, Falkland Islands, Faroe Islands, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Gibraltar, Grenada, Greece, Greenland, Guadeloupe, Guernsey, Guinea, Guinea Bissau, Guatemala, Guyana, Haiti, Heard Island and McDonald, Hong Kong, Hungary, Iceland, India, Ireland, Iran, Iraq, Israel, Italy, Jamaica, Jersey, Jordan, Kiribati, Kosovo, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar, Malawi, Maldives, Mali, PMA P180001: FDA Summary of Safety and Effectiveness Data Page 6 {6} Malta, Malaysia, Martinique, Mauritania, Mauritius, Mayotte, Federated states of Micronesia, Monaco, Mongolia, Montserrat, Mozambique, Namibia, Nauru, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Niue, Niger, Nigeria, Norfolk Island, Norway, Oman, Palau, Panama, Paraguay, Peru, Pitcairn, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena, Saint Kitts and Nevis, Saint Lucia, Saint Pierre and Miquelon, Saint Vincent and the Grenadine, San Marino, Sao Tome and Principe, Senegal, Seychelles, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Georgia and the South Sandwich Islands, South Africa, Southern Territories, Spain, Suriname, Svalbard and Jan Mayen, Sweden, Swaziland, Switzerland, Taiwan, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turks and Caicos Islands, Tuvalu, United Arab Emirates, Uganda, United Kingdom, Vanuatu, Vatican City State, Vietnam, Wallis and Futuna, Western Sahara, Zambia, and Zimbabwe. ## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Below is a list of potential adverse effects (e.g., complications) associated with the use of the device. - Amputation - Anesthetic complications and subsequent problems (e.g., aspiration) - Aortic enlargement - Aortic rupture and death - Aortic damage, including perforation, dissection, bleeding, and rupture - Arterial or venous thrombosis and/or pseudoaneurysm - Bleeding, hematoma, or coagulopathy - Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis) - Cardiac complications and subsequent problems (e.g., arrhythmia, tamponade, myocardial infarction, congestive heart failure, hypotension, hypertension) - Claudication (e.g., buttock, lower limb) - Death - Dissection extension (i.e., either proximal or distal extension) - Edema - Embolization (micro and macro) with transient or permanent ischemia or infarction - Endoleak - Endoprosthesis: improper component placement; incomplete component deployment; poor conformability of the graft to the vessel wall; component migration and/or separation; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; and perigraft flow; - Fever and localized inflammation - Fistula (e.g., aortobronchial, aortoesophageal, arteriovenous) - Genitourinary complications and subsequent problems (e.g., ischemia, erosion, fistula, urinary incontinence, hematuria, infection) - Hepatic failure - Impotence - Infection of the dissection, device, or access site, including abscess formation, transient fever, and pain PMA P180001: FDA Summary of Safety and Effectiveness Data Page 7 {7} - Local or systemic neurologic complications and subsequent problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis, spinal cord shock, paralysis) - Lymphatic complications and subsequent problems (e.g., lymph fistula, lymphocele) - Occlusion of device or native vessel - Persisting flow in the false lumen - Pulmonary/respiratory complications and subsequent problems (e.g., pneumonia, respiratory failure, prolonged intubation) - Renal complications and subsequent problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure) - Surgical conversion to open repair - Unintentional dissection septum rupture - Vascular access site complications including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula - Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death) - Wound complications and subsequent problems (e.g., dehiscence, infection) For the specific adverse events that occurred in the clinical studies, please see Section X below. ## IX. SUMMARY OF NONCLINICAL STUDIES The following nonclinical studies were performed on the Zenith Dissection Endovascular System: ## A. Biocompatibility Testing The Zenith Dissection Endovascular System utilizes the same materials, suppliers, and sterilization processes that have been previously accounted for in the biocompatibility testing for other approved Cook products. Specifically, the Zenith Dissection Endovascular System implants are constructed of the same base raw nitinol, stainless steel, polyester, and polypropylene materials as are used in the Zilver® Vascular Stent (P050017), the Zenith Flex® AAA Endovascular Graft (P020018), Zenith® Spiral-Z® AAA Iliac Leg Graft (P020018/S037), the Zenith TX2 TAA Endovascular Graft (P070016), and the Zenith® Alpha Thoracic Endovascular Graft (P140016). These devices have shown acceptable biocompatibility and have a history of safe clinical use in humans. Although there are some differences in manufacturing processes between the currently marketed devices and the subject device, rationale was provided to support that these do not raise any significant biocompatibility concerns. Therefore, additional biocompatibility studies specific to the Zenith Dissection Endovascular System implant were considered unnecessary. Likewise, the materials and suppliers used in the introduction systems for the Zenith Dissection Endovascular System are also used in the introduction systems for the above PMA P180001: FDA Summary of Safety and Effectiveness Data Page 8 {8} noted Zenith Endovascular Grafts, which have established biocompatibility. Although there are some differences in manufacturing and sterilization processes between the approved devices and the subject device, rationale was provided to support that differences do not raise any significant biocompatibility concerns. Therefore, biocompatibility testing was leveraged from other Zenith Endovascular Grafts devices in support of the Zenith Dissection Endovascular System introduction system. ## B. Laboratory Studies The laboratory studies completed to evaluate each component of the Zenith Dissection Endovascular System, as well as the combination of the Dissection Endovascular Graft with Dissection Stent, are presented separately below. All testing was completed in accordance with international standards, specifically ISO 25539-1 “Cardiovascular implants -- Endovascular devices -- Part 1: Endovascular prostheses.” Testing was completed using either all available sizes or a subset of device configurations and sizes to represent the full range available. ## Dissection Endovascular Graft Testing for the Dissection Endovascular Graft was focused on the unique attributes and use conditions as compared to the Zenith TX2 TAA Endovascular Graft and Zenith Flex AAA Endovascular Graft. Because of the similarities between the devices, the only new test that was performed on the Dissection Endovascular Graft implant alone was migration resistance, the results of which are summarized in Table 1. Sufficient rationale was provided to support leveraging all other implant only, delivery system only, and system testing in support of the Dissection Endovascular Graft. Table 1. Summary of laboratory (in vitro) test results for the Dissection Endovascular Graft (implant only) | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | Migration Resistance | To determine the maximum force required to pull the implant from aortic tissue (i.e., the force to cause migration). | A minimum pull-out force of 8.14 N | Shortest available Dissection Endovascular Graft with lowest radial force stents | Pass | ## Dissection Endovascular Stent Testing for the Dissection Stent was focused on the unique attributes and use conditions as compared to the Zenith TX2 TAA Endovascular Graft, Zenith Flex AAA Endovascular Graft, and Zenith Alpha Thoracic Endovascular Graft. Table 2 summarizes the new testing completed on the implant only. Table 3 presents testing completed utilizing the implant and delivery system to further support the Dissection Stent. Sufficient rationale was provided to support leveraging all other implant only, delivery system only, and system testing from other currently marketed Zenith devices. PMA P180001: FDA Summary of Safety and Effectiveness Data {9} Table 2. Summary of laboratory (in vitro) test results for the Dissection Stent (implant only) | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | Dimensional Verification | To measure the relaxed length and outside diameter of the implant. | Length ± 10 mm of the label; distal end diameter ± 5% of the label; flared proximal end stent diameter measured for characterization purposes only | Largest diameter and longest length Dissection Stent | Pass | | Radial Force/Hoop Strength | To determine the outward radial force exerted by the implant when its diameter is reduced by mechanical constriction. | Minimum/Maximum 1.0 N ≤ x ≤ 7.0 N | All z-stent configurations used in the construction of the Dissection Stent | Pass | | Corrosion | To evaluate corrosion resistance (breakdown potential) | The breakdown potential shall be statistically greater than or equivalent to that of a nitinol stent used in an approved endovascular stent-graft | Dissection Stent z-stent configuration under the most strain when compressed to the introducer diameter | Pass | | Stress/strain Analysis (FEA) | To evaluate the fatigue behavior of the implant under physiologically relevant loading conditions. | Fatigue safety factor must be > 1.0. | All z-stent configurations used in the construction of the Dissection Stent | Pass | Table 3. Summary of laboratory (in vitro) test results for the Dissection Stent (system) | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | Profile/Diameter | To measure the outer diameter of the loaded system intended for insertion into the vasculature. | Testing was performed for characterization purposes only | All Dissection Stent diameters and lengths | 46 mm diameter stent 6.22 ± 0.03 mm 6.21 ± 0.01 mm 6.23 ± 0.02 mm 36 mm diameter stent 6.20 ± 0.02 mm 6.23 ± 0.02 mm 6.23 ± 0.01 mm | | Simulated Use and Visibility | To examine characteristics related to the geometry and deployment of stent components, and to obtain measurements and/or photographs of the geometry and deployment characteristics of these components. | 100% success for all parameters important to proper deployment, including: • flushing • advancement visibility of tapered tips, sheath, and stents • sheath pullback • stent components remain attached to delivery system after sheath pullback • smooth trigger-wire release • devices expand • stents positioned correctly in the anatomic model • sub-assembly and sheath removal | All Dissection Stent diameters and lengths | Pass | PMA P180001: FDA Summary of Safety and Effectiveness Data {10} | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | | | • valves remain in place after withdrawal of the grey positioner • no visible debris • stents have no kinks, bends, twisting, component separation, or damage to it or delivery system after deployment | | | | Force to Deploy | To measure the force required to deploy a stent component inside an anatomical model. | Maximum sheath withdrawal force < 45 N Pull-out force of the release wire < 36 N | Largest diameter and longest length Dissection Stent | Pass | # Zenith Dissection Endovascular System Additional testing of the Dissection Endovascular Graft in combination with the Dissection Stent was also performed, taking into consideration the intended use conditions. Table 4 summarizes the completed testing. Table 4. Summary of laboratory (in vitro) test results for the Zenith® Dissection Endovascular System (Dissection Endovascular Graft in combination with Dissection Stent). | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | Corrosion | To evaluate the corrosion resistance of the implant. | No acceptance criterion for this test; the assessment of galvanic corrosion behavior of the coupled materials is for characterization purposes only | 1. Dissection Stent (Niti) 2. TX2 Stent (304 SS) 3. Gold Markers | Uncoupled corrosion tests Icors: 1. 0.457 ± 0.440 nA/mm² 2. 0.009 ± 0.004 nA/mm² 3. 1.112 ± 1.044 nA/mm² Uncoupled corrosion tests Ecorr: 1. -91 ± 89 mVSCE 2. -72 ± 25 mVSCE 3. -217 ± 145 mVSCE Coupled galvanic corrosion testing measured Icouple: 2. 0.03 ± 0.02 nA/mm² 3. 0.01 ± 0.02 nA/mm² Coupled galvanic corrosion testing Ecouple: 2. -95.4 ± 51.2 mVSCE 3. -74.9 ± 27.5 mVSCE | PMA P180001: FDA Summary of Safety and Effectiveness Data {11} | Test | Purpose | Acceptance Criteria | Types/Sizes Tested | Results | | --- | --- | --- | --- | --- | | Fatigue & Durability | To evaluate the fatigue life of the implant by subjecting it to time-accelerated, physiologically modeled, controlled displacement pulsatile loading for a specified number of cycles. | No through-strut stent fractures shall occur in the stents at any point through the duration of 400 million cycles of simulated pulsatile fatigue | Lowest safety factor Dissection Stent tested while overlapped with a Dissection Endovascular Graft of the same size | No fractures were observed in any of the stents that were subjected to 400 million pulsation cycles. | | MRI | To assess magnetic field interactions, RF (radiofrequency) heating, and MRI induced image artifacts for the implant. | Magnetic Field Interactions The measured force and torque at the maximum labeled force product (spatial gradient x magnetic field) shall be less than the forces required to rupture or transect dissected tissue or cause the device to migrate. RF Heating The Cumulative Equivalent Minutes at 43°C value shall be less than 10 minutes at the labeled Specific Absorption Rate limit. Image Artifact There is no acceptance criterion associated with image artifact. | Largest diameter and longest length Dissection Stent and Dissection Endovascular Graft | Pass Maximum artifact size extended approximately 80 mm relative to the graft overlapped with the stent; the lumen was completely obscured. | ## C. Shelf-life Testing Due to similarities in device design between the Zenith Dissection Endovascular System and other currently marketed Zenith devices, no new non-clinical testing was completed to support a three-year shelf-life claim. The materials used in the Zenith Dissection Endovascular System are the same as those used in the Zenith TX2 TAA Endovascular Graft (P070016 and P070016/S002), except for the hemostatic valve, which is the same as that used for the Zenith Alpha™ Thoracic Endovascular Graft (P140016), and the hydrophilic coating on the sheath, which is the same as for the Zenith Spiral-Z Iliac Leg Graft (P020018/S037). Each of the prior approved devices has an established three-year shelf-life and the information to support the three-year shelf-life for the other products is appropriate to leverage for the Zenith Dissection Endovascular System, thereby supporting a three-year expiration date. ## D. Animal Studies The Zenith Dissection Endovascular System shares the same basic design as the Zenith TX2 TAA Endovascular Graft, a cylindrical endovascular prosthesis with self-expanding z-stents that are bare or are sutured to the internal or external surface of graft material. PMA P180001: FDA Summary of Safety and Effectiveness Data {12} Moreover, the Zenith Dissection Endovascular System is constructed of the same base raw nitinol, stainless steel, polyester, and polypropylene materials with similar processing as the Zilver Vascular Stent (P050017), the Zenith Flex AAA Endovascular Graft (P020018), and the Zenith TX2 TAA Endovascular Graft (P070016). These devices underwent previous animal testing and demonstrated acceptable results with respect to patency (freedom from thrombosis) and biological response (histopathology). Additionally, these devices have shown acceptable biocompatibility and have a history of safe clinical use in humans. Therefore, animal studies from prior Cook devices were leveraged in support of the Zenith Dissection Endovascular System. ## X. SUMMARY OF THE PRIMARY CLINICAL STUDY The applicant performed a pivotal clinical study to establish a reasonable assurance of safety and effectiveness of endovascular treatment with the Zenith® Dissection Endovascular System for Type B aortic dissection in the US and Japan under IDE# G070123. Data from this clinical study were the basis for the PMA approval decision. The Zenith Dissection Endovascular System is a line extension to the Zenith family of endovascular devices. The Dissection Endovascular Graft is similar to other endovascular grafts in the product line, but is designed specifically for the treatment of dissections, having no barbs. Information from previous clinical studies and clinical use of the Zenith endovascular grafts provides a foundation for the expected clinical performance of the Dissection Endovascular Graft, including placement in aneurysmal aortic segments. The clinical study of the Zenith Dissection Endovascular System enrolled patients with acute, complicated dissections and included implantation of the Dissection Endovascular Graft and the Dissection Stent. Data from the clinical study performed on use of Zenith Dissection Endovascular System for the treatment of acute, complicated Type B aortic dissection are presented below. Refer to Section XI for supplementary information that supported a broader indication inclusive of chronic dissection. ## A. Study Design Patients were treated between August 4, 2012 and January 15, 2015. The database for this PMA reflected data collected through March 14, 2017 and included 73 patients (67 US, 6 Japan). There were 22 investigational sites (21 US, 1 Japan). The study was a prospective, non-randomized, single-arm, multi-national / multi-center clinical study based on binomial distribution for hypothesis testing. Because acute, complicated dissections are life threatening, the primary endpoint for the study was the survival rate at 30 days. The performance goal for this endpoint (79.4%) was an adjusted rate based on the survival rate at 30 days in the Society of Vascular PMA P180001: FDA Summary of Safety and Effectiveness Data Page 13 {13} Surgery (SVS) dataset, which includes pooled data from physician-sponsored studies reported by the SVS Outcomes committee. Null Hypothesis: The survival rate at 30 days, $\pi_{\mathrm{s}(30)}$, does not meet the performance goal (79.4%). H₀: $\pi_{\mathrm{s}(30)} \leq 79.4\%$ Alternate Hypothesis: The survival rate at 30 days, $\pi_{\mathrm{s}(30)}$, meets the performance goal (79.4%). Hₐ: $\pi_{\mathrm{s}(30)} &gt; 79.4\%$ There was an additional hypothesis-driven safety endpoint of freedom from Major Adverse Events (MAEs) at 30 days. The performance goal for this endpoint (51.2%) was an adjusted rate based on the rate of freedom from MAEs at 30 days in the SVS dataset. Null Hypothesis: The freedom from MAE at 30 days, $\pi_{\mathrm{s}(30)}$, does not meet the performance goal (51.2%). H₀: $\pi_{\mathrm{s}(30)} \leq 51.2\%$ Alternate Hypothesis: The freedom from MAE at 30 days, $\pi_{\mathrm{s}(30)}$, meets the performance goal (51.2%). Hₐ: $\pi_{\mathrm{s}(30)} &gt; 51.2\%$ Forty patients were necessary to assess the primary hypothesis, under an expected 30-day survival rate of $94.9\%$ (estimated from a feasibility study conducted under G070123 for a previous design of the dissection graft and stent), with a one-sided exact binomial test, at a type I error rate of 0.025 and a power of 0.8. Sixty patients were necessary to assess the additional hypothesis-driven endpoint, under an expected rate of freedom from 30-day MAE at $69.2\%$ (estimated from a feasibility study conducted under G070123 for a previous design of the dissection graft and stent), with a one-sided exact binomial test, at a type I error rate of 0.025 and a power of 0.8. A sample size of 67 was initially established to account for possible loss to follow-up. During the course of the study, the sample size was increased to 73 patients in order to account for six previously enrolled US patients who should have been excluded from the study according to additional medical exclusion criteria that were implemented subsequent to enrollment initiation (none of the six had confirmed absence of bowel necrosis at the time of enrollment). While the data from all 73 patients enrolled in the study are reported (enrollment IDs for the six excluded patients are italicized and indicated by footnotes where applicable), the hypotheses were assessed based on the 67 patients enrolled according to the inclusion/exclusion criteria. All other endpoints were analyzed descriptively. Even though the endpoints are at 30-days, data through the 12-month post-procedure was required and has been provided on all surviving patients. This provides information on the ability of the Dissection Endovascular Graft to seal entry tears covered by the device PMA P180001: FDA Summary of Safety and Effectiveness Data Page 14 {14} and the ability of the Dissection Stent to provide support to delaminated segments of aortic dissections distal to the Dissection Endovascular Graft. An independent core laboratory analyzed all patient imaging. An independent clinical events committee (CEC) adjudicated at a minimum all patient deaths, conversions to open repair, rupture, Type A dissections, and stroke. An independent data safety monitoring board (DSMB) monitored the clinical trial according to an established safety monitoring plan. ## 1. Clinical Inclusion and Exclusion Criteria Enrollment in the study was limited to patients who had an acute, complicated, Type B aortic dissection with at least one of the following characteristics: - Aortic rupture; or - Branch vessel obstruction/compromise resulting in malperfusion Patients were not permitted to enroll in the study if they met any of the following exclusion criteria: ### General Exclusion Criteria - Age &lt; 18 years (&lt; 20 years for Japan); - Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be noncompliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years); - Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; - Unwilling or unable to comply with the follow-up schedule; - Inability or refusal to give informed consent; or - Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) ### Medical Exclusion Criteria - Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, and/or acidosis) - American Society of Anesthesiologists (ASA) risk class V (i.e., moribund patient not expected to live 24 hours with or without operation) - Embolic stroke within the last 14 days prior to potential enrollment in the study or hemorrhagic stroke within 30 days prior to potential enrollment in the study; - Diagnosed or suspected congenital degenerative connective tissue disease (e.g., no Marfan’s or Ehler-Danlos syndrome); - Systemic infection (e.g., sepsis); - Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion; - Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold; PMA P180001: FDA Summary of Safety and Effectiveness Data Page 15 {15} - Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately pre-medicated; - Surgical or endovascular abdominal aortic aneurysm (AAA) repair within 30 days before or after dissection repair; - Previous placement of a thoracic endovascular graft; - Prior open repair involving descending thoracic aorta including suprarenal aorta and/or arch; or - Interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair. ## Anatomical Exclusion Criteria - Dissection of aorta proximal to left subclavian artery (either primary entry tear or most proximal extent of dissection); - Proximal stent-graft component: - Aortic arch radius of curvature &lt; 35 mm (if device deployed in the arch); - Proximal landing zone length measuring &lt; 20 mm between the left common carotid artery and most proximal extent of dissection (covering left subclavian artery is acceptable, except in patients with a dominant vertebral artery off of the arch in the region of the subclavian or a dominant vertebral off of the subclavian); - Proximal landing zone diameter for proximal stent-graft component &lt; 20 mm or &gt; 38 mm, measured outer-wall to outer-wall on a sectional image or multiplanar reconstruction; - Distal landing zone diameter for proximal stent-graft component &lt; 20 mm (estimate based on transaortic diameter) or &gt; 38 mm (estimate based on true lumen diameter), measured outer-wall to outer-wall on a sectional image or multiplanar reconstruction; - Prohibitive calcification, occlusive disease, or angulation in intended proximal landing zone; - Circumferential thrombus in region of intended proximal landing zone; - Inability to preserve the native left common carotid artery and celiac artery origins; - Distal bare stent component: - Diameter &lt; 20 mm (estimate based on transaortic diameter) or &gt; 38 mm (estimate based on true lumen diameter) for any segment of vessel into which deployment of bare stent device is intended, measured outer-wall to outer-wall on a sectional image or multiplanar reconstruction; - Prohibitive angulation in segments of vessel into which deployment of bare stent device is intended (e.g., radius of curvature &lt; 35 mm, or localized angle &gt; 45 degrees); - Both iliac arteries having prohibitive tortuosity, calcification, occlusive disease or arterial diameter, measured inner-wall to inner-wall on a sectional image, that are not conducive to placement of the introducer sheath (use of access conduit permitted); or - Aneurysm or angulation in the distal thoracic aorta that would preclude advancement of the introduction system. PMA P180001: FDA Summary of Safety and Effectiveness Data Page 16 {16} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 17 # 2. Follow-up Schedule All patients were scheduled to return for follow-up examinations at 30 days, 6 months, 12 months, and then annually through 5 years postoperatively. Preoperatively, patients underwent a clinical exam, blood test, and CT scan, as also shown in Table 5. Postoperatively, the objective parameters measured during the study based on CT included assessment of the total aortic, true lumen, and false lumen diameters at multiple locations, presence of and sources for false lumen flow, extent of false lumen thrombosis, progression of dissection, branch vessel patency, and device position and integrity. Adverse events and complications were recorded at all visits. The key timepoints are shown below in Table 5 as well as the tables that follow summarizing safety and effectiveness. Table 5. Study follow-up schedule | | Pre-operative | Intra-operative | Post-procedure | 30-day (± 10 days) | 6-month (± 30 days) | 12-month (± 45 days) | 2-year to 5-year^{e} | | --- | --- | --- | --- | --- | --- | --- | --- | | Clinical exam | X | | X | X | X | X | X | | Blood testsa | X | | X | X | X | X | X^{f} | | Contrast CT scan | X | | X^{c,d} | | X^{c} | X^{c} | X^{c} | | Angiography | X^{b} | X | | | | | | a Including tests to evaluate kidney and liver function. b Required only to resolve any uncertainties in anatomical measurements necessary for graft sizing. c Transesophageal echocardiography (TEE) or non-contrast CT imaging may be used for those patients experiencing documented renal failure (eGFR&lt; 30) or who are otherwise unable to undergo contrast enhanced CT scan. d CT must be performed prior to hospital discharge. In case of impaired renal function at the time of discharge, CT may be performed at 30 days. e 2 years (730 ± 60 days), 3 years (1095 ± 60 days), 4 years (1460 ± 90 days), and 5 years (1825 ± 90 days). f Required only for patients with malperfusion that has not stabilized. # 3. Clinical Endpoints With regards to safety and effectiveness, the primary endpoint is the survival rate at 30 days. With regards to safety, an additional hypothesis-driven endpoint for the study was freedom from major adverse events (MAEs) at 30 days. MAEs were defined as the following: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged (&gt; 72 hours) ventilatory support. With regards to success/failure criteria, the study would be considered successful if both performance goals were met. Additional (secondary) endpoints that were evaluated, not for the purpose of statistical inference, included changes in total aortic, true and false lumen size, presence of and sources for false lumen flow, extent of false lumen thrombosis, progression of dissection, {17} branch vessel patency, secondary interventions, and device migration and integrity. ## B. Accountability of PMA Cohort At the time of the database lock, of 73 patients enrolled in the PMA study, 94.5% (69) were available for 30-day follow-up and 78.1% (57) were available for 12-month follow-up, as there were 4 deaths within 30 days and 9 deaths as well as 3 patients who withdrew from the study or became lost to follow-up between the 30-day and 12-month visits. Table 6 reports the follow-up availability through 12 months. Of the 73 patients enrolled in the study, 79.5% (58) received at least one Dissection Endovascular Graft and one Dissection Stent during the index procedure, while the remaining 20.5% (15) received only a Dissection Endovascular Graft, not a Dissection Stent. Although the study was not powered to assess for differences in outcomes based on the different component combinations (namely the presence vs. absence of a Dissection Stent), the results were analyzed and reported separately for the following groups where appropriate: total patient population, cohort with a Dissection Stent, and cohort without a Dissection Stent. Table 6. Follow-up availability | Follow-up Visitc | Patients Eligible for Follow-up | Percent of Data Available (Site) | | Adequate Imaging to Assess the Parameter (Core Lab) | | | | | | Events Occurring Before Next Interval | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | Clinical Assessment | CTa | Size Increase in Stent-graft | Size Increase in Dissection Stentb | Entry-flow in Thoracic Aorta | Entry-flow in Abdominal Aorta | Migration | Device Integrity | Death | Conversion | LTF/WTH D | Not Due for Next Visit | | Postoperati ve | 73 | 100.0% (73/73) | 53.4% (39/73) | NA | NA | 45.2% (33/73) | 45.2% (33/73) | NA | 49.3% (36/73) | 4 | 0 | 0 | 0 | | 30-day | 69 | 97.1% (67/69) | 76.8% (53/69) | NA | NA | 71.0% (49/69) | 68.1% (47/69) | NA | 75.4% (52/69) | 1 | 0 | 1 | 0 | | 6-month | 67 | 77.6% (52/67) | 83.6% (56/67) | 98.2% (55/67) | 84.6% (44/52) | 76.1% (51/67) | 70.1% (47/67) | 74.6% (50/67) | 83.6% (56/67) | 8 | 0 | 2 | 0 | | 12-month | 57 | 86.0% (49/57) | 89.5% (51/57) | 92.2% (47/57) | 84.8% (39/46) | 82.5% (47/57) | 78.9% (45/57) | 80.7% (46/57) | 86.0% (49/57) | 2 | 0 | 4 | 1 | LTF: lost-to-follow-up; WTHD: withdrawal. a Per clinical investigation plan amendment 11-007-04, a patient is required to have a CT scan prior to discharge unless the patient has renal issues; in this case, the patient will have the CT scan completed at the 1-month visit. b Size increase in Dissection Stent assessment only applies to patients who received a Dissection Stent. c Follow-up visit windows as follows: 30 days (± 10 days), 6 months (180 ± 30 days), 12 months (365 ± 45 days). PMA P180001: FDA Summary of Safety and Effectiveness Data {18} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 19 # C. Study Population Demographics and Baseline Parameters The demographics and baseline parameters of the study population are typical for an acute, complicated Type B aortic dissection study performed in the US. The demographics, pre-existing comorbid medical conditions, and presenting complications were compared between this study and SVS dataset to support the use of the performance goals based on the SVS dataset. Comparisons were also made between two patient groups within the study; patients who received and patients who did not receive a Dissection Stent. Partially due to the small number of patients, few statistically significant differences were found when comparing populations, despite numerical differences. None of the differences were found to be clinically meaningful with respect to supporting the performance goals. Some of the differences in the patient groups within the study population are likely associated with the greater percentage of patients who did not receive the Dissection Stent having been treated for rupture rather than malperfusion. Comparisons are not presented between the US and Japanese patients as only 6 patients were treated in Japan. Four patients presented with rupture, one patient presented with rupture and malperfusion, and one patient presented with malperfusion alone; none received the Dissection Stent. # Demographics The demographics and patient characteristics are presented in Table 7. Of the demographic and patient data in the present study compared with that of the SVS dataset, only the ethnicity/race distribution was significantly different $(p = 0.046)$ , which is not expected to be clinically significant with respect to evaluating the safety and effectiveness endpoints. Similarly, with the exception of the ethnicity distribution, the demographics appeared comparable between patients who either received or did not receive a Dissection Stent. Table 7. Demographics and patient characteristics | Demographic | Mean ± SD (N, range) or Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | All Pivotal Patients | SVS Acute Patients | | Age (years) | | | | | | All patients | 65.1 ± 13.1 | 59.5 ± 10.1 | 60.7 ± 10.9 | 58.8 ± 15.4 | | | (15, 42 - 81) | (58, 34 - 77) | (73, 34 - 81) | (85, 25.9 - 88.6) | | Gender | | | | | | Male | 53.3% (8/15) | 69.0% (40/58) | 65.8% (48/73) | 72.9% (62/85) | | Female | 46.7% (7/15) | 31.0% (18/58) | 34.2% (25/73) | 27.1% (23/85) | {19} | Ethnicity/RaceaWhite | 33.3% (5/15) | 67.2% (39/58) | 60.3% (44/73) | 52.9% (45/85) | | --- | --- | --- | --- | --- | | Hispanic or Latino | 0% | 5.2% (3/58) | 4.1% (3/73) | 14.1% (12/85) | | Black or African | 20.0% (3/15) | 25.9% (15/58) | 24.7% (18/73) | 27.1% (23/85) | | American | | | | | | First NationsbAsian | 0% | 0% | 0% | 2.4% (2/85) | | | 46.7% (7/15) | 1.7% (1/58) | 11.0% (8/73) | 3.5% (3/85) | | Height (in) | 64.4 ± 3.6 | 68.5 ± 4.4 | 67.7 ± 4.5 | NC | | | (15, 59.8 - 72.0) | (58, 59 - 76) | (73, 59 - 76) | | | Weight (lbs) | 168.1 ± 39 | 202.5 ± 56.0 | 195.4 ± 54.5 | NC | | | (15, 116.0 - 255.7) | (58, 101.4 - 357.1) | (73, 101.4 - 357.1) | | | Body mass index(BMI) | 28.4 ± 5.5 | 30.0 ± 7.2 | 29.7 ± 6.9 | NC | | | (15, 21.4 - 40.0) | (57, 16.3 - 50.6) | (72, 16.3 - 50.6) | | NC: not collected. a Ethnicity/race distribution difference was significant between the pivotal study and SVS dataset $(p = 0.046)$ . b First Nations includes American Indian/Alaskan Native, and Native Hawaiian/Pacific Islander. # Medical History and Comorbidities Medical history and comorbid conditions are presented in Table 8. None of the differences in the medical histories of patients enrolled in the present study and those recorded in the SVS dataset are statistically significant. A history of aneurysm or dissection is the biggest difference in patient groups within the study, being more prevalent in patients that did not receive a Dissection Stent. Table 8. Medical history and comorbid conditions | Medical History | Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | All Pivotal Patients | SVS Acute Patients | | Cardiovascular | | | | | | Previous myocardial infarction | 13.3% (2/15) | 3.4% (2/58) | 5.5% (4/73) | 11.8% (10/85) | | Previous symptomatic congestive heart failure | 0% (0/15) | 3.4% (2/58) | 2.7% (2/73) | 10.6% (9/85) | | Coronary artery disease | 20.0% (3/15) | 15.5% (9/58) | 16.4% (12/73) | NC | | Cardiac arrhythmia | 20.0% (3/15) | 13.8% (8/58) | 15.1% (11/73) | 11.8% (10/85) | | Vascular | | | | | | Thromboembolic event | 0% | 8.6% (5/58) | 6.8% (5/73) | NC | | Peripheral vascular disease | 6.7% (1/15) | 3.4% (2/58) | 4.1% (3/73) | 2.4% (2/85) | | Family history of aneurysm or dissection | 0% | 6.9% (4/58) | 5.5% (4/73) | NC | | Patient history of aneurysm or dissection | 60.0% (9/15) | 22.4% (13/58) | 30.1% (22/73) | NC | | Hypertension | 100.0% (15/15) | 82.8% (48/58) | 86.3% (63/73) | 83.5% (71/85) | | Previous thoracic surgery or thoracic trauma | 26.7% (4/15) | 10.3% (6/58) | 13.7% (10/73) | NC | | Aortobronchial fistula | | | | | | Aortoesophageal fistula | 0% | 0% | 0% | NC | | Bleeding diathesis or uncorrectable coagulopathy | 0% | 0% | 0% | NC | PMA P180001: FDA Summary of Safety and Effectiveness Data {20} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 21 | Medical History | Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | All Pivotal Patients | SVS Acute Patients | | Carotid endarterectomy | 0% | 0% | 0% | NC | | Diagnosed or suspected congenital degenerative collagen disease | 0% | 0% | 0% | NC | | Pulmonary | 40.0% (6/15) | 15.5% (9/58) | 20.5% (15/73) | 10.6% (9/85) | | Chronic obstructive pulmonary disease | | | | | | Renal | 6.7% (1/15) | 8.6% (5/58) | 8.2% (6/73) | 7.1% (6/85) | | Chronic renal insufficiency or dialysis | | | | | | Endocrine | 0% | 5.2% (3/58) | 4.1% (3/73) | 12.9% (11/85) | | Diabetes | | | | | | Infectious disease | 0% | 0% | 0% | NC | | Previous diagnosis of sepsis | | | | | | Hepatobiliary | 6.7% (1/15) | 1.7% (1/58) | 2.7% (2/73) | 0% (0/85) | | Liver disease | | | | | | Neoplasms | 20.0% (3/15) | 8.6% (5/58) | 11.0% (8/73) | 9.4% (8/85) | | Cancer | | | | | | Neurologic | 13.3% (2/15) | 5.2% (3/58) | 6.8% (5/73) | NC | | Stroke | 6.7% (1/15) | 5.2% (3/58) | 5.5% (4/73) | 1.2% (1/85) | | Paraparesis | 0% 6.7% (1/15) | 3.4% (2/58) | 2.7% (2/73) | 2.4% (2/85) | | Paralysis | | | | | | Transient ischemic attack | | 3.4% (2/58) | 4.1% (3/73) | 0% (0/85) | | Smoking | 13.3% (2/15) | 31.0% (18/58) | 27.4% (20/73) | 37.3% (31/83) | | Past | 40.0% (6/15) | 50.0% (29/58) | 47.9% (35/73) | 31.8% (27/83) | | Current | 46.7% (7/15) | 19.0% (11/58) | 24.7% (18/73) | 30.1% (25/83) | | Never | | | | | NC: not collected. ## ASA Classification Table 9 reports the ASA classification. The distribution of ASA physical status classifications in the present study was statistically different from that in the SVS dataset, with the SVS patients having more severe disease. However, due to the subjective nature of the ASA classification, and considering the similarities between the present study and the SVS dataset for most other variables, the difference is not considered clinically significant with respect to establishing the performance goals. The majority of patients were class 4 in both the group with a Dissection Stent and group without a Dissection Stent. Table 9. ASA physical status classification | ASA Classification* | Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | SVS | | Healthy patient (1) | 0% | 0% | 0% | 0% | {21} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 22 | Mild systemic disease (2) | 20.0% (3/15) | 5.2% (3/58) | 8.2% (6/73) | 2.4% (2/85) | | --- | --- | --- | --- | --- | | Severe systemic disease (3) | 20.0% (3/15) | 29.3% (17/58) | 27.4% (20/73) | 22.4% (19/85) | | Incapacitating systemic disease (4) | 60.0% (9/15) | 65.5% (38/58) | 64.4% (47/73) | 64.7% (55/85) | | Moribund patient (5) | 0% | 0% | 0% | 10.6% (9/85) | $^{a}$ ASA classification distribution difference was significant between the present study and the SVS dataset $(p = 0.008)$. ## SVS-ISCVS Risk Score Table 10 reports the Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS-ISCVS) risk score. The SVS-ISCVS risk scores were consistent with the preexisting comorbid conditions for the patient population in the present study. Of the distribution of risk scores, patients who received a Dissection Stent were more likely to present with higher smoking risk scores and higher renal status risk scores, leading to higher total risk scores. SVS-ISCVS risk scores were not reported in the SVS dataset. Table 10. SVS-ISCVS risk score classification | SVS-ISCVS Category | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | | Diabetes risk score | | | | | 0 | 100.0% (15/15) | 93.1% (54/58) | 94.5% (69/73) | | 1 | 0% | 5.2% (3/58) | 4.1% (3/73) | | 2 | 0% | 0% | 0% | | 3 | 0% | 1.7% (1/58) | 1.4% (1/73) | | 4 | 0% | 0% | 0% | | Smoking risk score | | | | | 0 | 53.3% (8/15) | 34.5% (20/58) | 38.4% (28/73) | | 1 | 6.7% (1/15) | 12.1% (7/58) | 11.0% (8/73) | | 2 | 33.3% (5/15) | 32.8% (19/58) | 32.9% (24/73) | | 3 | 6.7% (1/15) | 20.7% (12/58) | 17.8% (13/73) | | Hypertension risk score | | | | | 0 | 6.7% (1/15) | 13.8% (8/58) | 12.3% (9/73) | | 1 | 33.3% (5/15) | 20.7% (12/58) | 23.3% (17/73) | | 2 | 20.0% (3/15) | 32.8% (19/58) | 30.1% (22/73) | | 3 | 40.0% (6/15) | 32.8% (19/58) | 34.2% (25/73) | | Hyperlipidemia risk score | | | | | 0 | 53.3% (8/15) | 56.9% (33/58) | 56.2% (41/73) | | 1 | 13.3% (2/15) | 12.1% (7/58) | 12.3% (9/73) | | 2 | 0% | 1.7% (1/58) | 1.4% (1/73) | | 3 | 33.3% (5/15) | 29.3% (17/58) | 30.1% (22/73) | | Cardiac status risk score | | | | | 0 | 86.7% (13/15) | 89.7% (52/58) | 89.0% (65/73) | | 1 | 13.3% (2/15) | 1.7% (1/58) | 4.1% (3/73) | | 2 | 0% | 6.9% (4/58) | 5.5% (4/73) | | 3 | 0% | 1.7% (1/58) | 1.4% (1/73) | | Carotid disease risk score | | | | {22} | SVS-ISCVS Category | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | | 0 | 93.3% (14/15) | 94.8% (55/58) | 94.5% (69/73) | | 1 | 6.7% (1/15) | 3.4% (2/58) | 4.1% (3/73) | | 2 | 0% | 0% | 0% (0/73) | | 3 | 0% | 1.7% (1/58) | 1.4% (1/73) | | Renal status risk score | | | | | 0 | 93.3% (14/15) | 62.1% (36/58) | 68.5% (50/73) | | 1 | 6.7% (1/15) | 31.0% (18/58) | 26.0% (19/73) | | 2 | 0% | 5.2% (3/58) | 4.1% (3/73) | | 3 | 0% | 1.7% (1/58) | 1.4% (1/73) | | Pulmonary status risk score | | | | | 0 | 80.0% (12/15) | 73.7% (42/57) | 75.0% (54/72) | | 1 | 6.7% (1/15) | 17.5% (10/57) | 15.3% (11/72) | | 2 | 0% | 5.3% (3/57) | 4.2% (3/72) | | 3 | 13.3% (2/15) | 3.5% (2/57) | 5.6% (4/72) | | Total SVS-ISCVS risk score (mean ± SD; N, range) | 4.7 ± 2.4 (15, 1 - 9) | 5.5 ± 2.9 (58, 0 - 12) | 5.4 ± 2.8 (73, 0 - 12) | ## Presenting Complications Presenting complications reported by the site are presented in Table 11. The percentage of patients with rupture, malperfusion, or rupture and malperfusion were comparable between the present study and the SVS dataset, though the patient population in the present study significantly more often presented with obstruction/compromise that also involved the gastrointestinal $(p &lt; 0.001)$ and renal/urologic branch vessels $(p = 0.011)$ . Patients who presented with rupture were less likely to receive a Dissection Stent than patients who presented with obstruction or compromise. Table 11. Presenting complications | Complication | Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | SVS | | Rupture | 73.3% (11/15) | 15.5% (9/58) | 27.4% (20/73) | 31.8% (27/85) | | Obstruction/compromise of branch vessel | 33.3% (5/15) | 89.7% (52/58) | 78.1% (57/73) | 71.8% (61/85) | | Gastrointestinal | 40.0% (2/5) | 59.6% (31/52) | 57.9% (33/57)a | 19.7% (12/61)a | | Renal/urologic | 60.0% (3/5) | 57.7% (30/52) | 57.9% (33/57)a | 36.1% (22/61)a | | Spinal cord | 0% | 5.8% (3/52) | 5.3% (3/57) | 3.3% (2/61) | | Lower extremity | 80.0% (4/5) | 53.8% (28/52) | 56.1% (32/57) | 55.7% (34/61) | | Other | 0% | 1.9% (1/52) | 1.8% (1/57) | 8.2% (5/61) | | Rupture and obstruction of branch vessel | 6.7% (1/15) | 5.2% (3/58) | 5.5% (4/73) | 3.5% (3/85) | | Persistent pain | 93.3% (14/15) | 91.4% (53/58) | 91.8% (67/73)a | 76.5% (65/85)a | | Size/growth of the transaortic diameter | 53.3% (8/15) | 15.5% (9/58) | 23.3% (17/73) | NC | PMA P180001: FDA Summary of Safety and Effectiveness Data {23} | Complication | Percent Patients (number/total number) | | | | | --- | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | SVS | | Periaortic effusion (without rupture) | 60.0% (9/15) | 12.1% (7/58) | 21.9% (16/73) | NC | | Resistant hypertension | 40.0% (6/15) | 27.6% (16/58) | 30.1% (22/73) | 43.5% (37/85) | NC: not collected. a Persistent pain, gastrointestinal, and renal/urologic obstruction/compromise of branch vessel distribution differences were significant between the present study and the SVS dataset $(p = 0.010, p &lt; 0.001$ , and $p = 0.011$ , respectively). # Baseline Vessel Measurements This section reports the results from core laboratory analysis of pre-procedure imaging. # Site vs Core Lab Measures Imaging was reviewed by the clinical study sites to determine adherence to the study selection criteria. All patients enrolled in the study were reported by the sites to meet the selection criteria. However, a total of 33 patients were measured by the core laboratory as having a length $&lt; 20\mathrm{mm}$ from the left common carotid (LCC) to the most proximal extent of dissection (Table 12), 25 of which also had a dissection that extended proximal to the left subclavian artery (LSA) according to initial assessments relative to anatomical landmarks (Table 14) or based on the Zone classification as also used to describe the extent of Dissection Endovascular Graft and Dissection Stent coverage at the time of the index procedure (Table 22, found in the Procedural Information Section). There were 11 additional patients (in whom the length from LCC to proximal extent was either not assessed or measured $\geq 20\mathrm{mm}$ by core lab) with a dissection that extended proximal the LSA based on the Zone classification. Refer to Figure 6 for an overview of these findings. PMA P180001: FDA Summary of Safety and Effectiveness Data {24} ![img-5.jpeg](img-5.jpeg) Figure 6. Core lab measurements of short necks and/or dissection proximal to the LSA Also of note, the maximum total aortic diameters (Table 12) in locations expected to coincide with likely fixation/seal zones (i.e., just distal to the LCC and just distal to the LSA) exceeded the maximum allowable diameter of $38\mathrm{mm}$ at pre-procedure $(n = 14$ which included 12 of the patients with a length $&lt; 20\mathrm{mm}$ from the LCC to proximal extent of dissection and/or a dissection that extended proximal to the LSA). While patients were to be excluded from the study if the length from the LCC to the most proximal extent of dissection was $&lt; 20\mathrm{mm}$ , if the dissection extended proximal to the LSA, or if the total aortic diameter was $&gt;38\mathrm{mm}$ in the proximal fixation zone, compliance with the protocol was based on information available at pre-procedure, as assessed by the site, and not the results from subsequent core laboratory analysis of pre-procedure imaging. All site assessments concurred with the requirements in the protocol. Nonetheless, it is important to note that all proximal post-treatment dissection events (4/4), ruptures (2/2), and proximal Type I entry-flow (7/7) within 365 days occurred in this subset of patients with anatomy beyond the intended use, underscoring the need to pay careful attention to these parameters during patient selection, as also emphasized in the labeling. # Length and Diameter Table 12 reports baseline anatomical measurements per the core laboratory (similar data were not reported in the SVS dataset). The overall results from core laboratory analysis PMA P180001: FDA Summary of Safety and Effectiveness Data {25} of pre-procedure imaging appear consistent with expectations for the intended study patient population, and the majority of the anatomical measurements for patients who received a Dissection Stent and for those who did not appeared comparable, with the exception of some diameters and lengths, as follows. With regards to length, patients who did not receive a Dissection Stent (patients who often presented with aortic rupture) typically exhibited more focal dissections (i.e., shorter length of dissected aorta) when compared to patients who received a Dissection Stent (patients who often presented with obstruction/compromise of branch vessels). Additionally, the average length of dissection $(408.9\mathrm{mm})$ in patients who received a Dissection Stent approached the total length of aorta from the left common carotid artery to the aortic bifurcation, thus indicating near complete involvement of the aorta with dissection. Overall, the trends in length were not surprising given the apparent difference in presenting complications between groups. With regards to diameter, patients who did not receive a Dissection Stent were more likely to have presented with larger transaortic diameters in the descending thoracic aorta, which is not surprising considering these patients were more often treated for rupture when compared to the patients who received a Dissection Stent. Patients who received a Dissection Stent were more likely to display larger false lumen diameters in the aorta distal to the descending thoracic aorta, specifically within the region of the branch vessels (aorta at the level of the celiac artery, SMA, and both renal arteries) as well as in the abdominal aorta, which is also not surprising considering these patients were more often treated for malperfusion when compared to patients who did not receive a Dissection Stent. Table 12. Baseline anatomical measurements per the core laboratory | Anatomical Measurements | Mean ± SD (N, range) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | | Length (mm) | | | | | LCC to most proximal extent of dissection | 26.8 ± 37.7(13, -11.1 to 118.4) | 23.9 ± 38.8(53, -109.2 to 191.5) | 24.5 ± 38.3(66, -109.2 to 191.5) | | LCC to most proximal aspect of primary tear | 93.5 ± 56.8(11, 5.9 - 208.8) | 112.2 ± 69.4(48, 0.9 - 281.7) | 108.7 ± 67.2(59, 0.9 - 281.7) | | From most proximal to most distal aspect of dissection | 315.9 ± 100.1(13, 129.3 - 468.9) | 408.9 ± 121.3(40, 125.2 - 637.2) | 386.1 ± 122.4(53, 125.2 - 637.2) | | Aortic arch radius of curvature (mm) | 26.6 ± 4.9 (15, 19 - 40) | 28.2 ± 7.0 (56, 13 - 47) | 27.8 ± 6.6 (71, 13 - 47) | | Largest angle in the descending thoracic aorta (degrees) | 32.7 ± 27.1 (14, 0 - 99) | 31.1 ± 26.6 (55, 0 - 175) | 31.4 ± 26.5 (69, 0 - 175) | PMA P180001: FDA Summary of Safety and Effectiveness Data Page 26 {26} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 27 | Anatomical Measurements | Mean ± SD (N, range) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | | Maximum aortic diameter (mm) | | | | | Just distal to LCC origin | | | | | True lumen | 32.0 ± 5.0 (15, 19.0 - 40.5) | 32.4 ± 4.3 (56, 16.3 - 43.8) | 32.4 ± 4.4 (71, 16.3 - 43.8) | | False lumen | 1.6 ± 4.9 (15, 0 - 18.5) | | | | Total | 33.6 ± 3.4 (15, 26.3 - 40.5) | 0.6 ± 2.6 (56, 0 - 16.1) | 0.8 ± 3.2 (71, 0 - 18.5) | | Just distal to LSA origin | | | | | True lumen | 27.8 ± 6.8 (15, 12.5 - 35.7) | 33.1 ± 4.1 (56, 25.7 - 43.8) | 33.2 ± 3.9 (71, 25.7 - 43.8) | | False lumen | 6.1 ± 8.8 (15, 0 - 26.7) | | | | Total | 33.9 ± 6.2 (15, 26.4 - 51.1) | 27.9 ± 4.6 (56, 18.2 - 40.3) | 27.9 ± 5.1 (71, 12.5 - 40.3) | | Descending thoracic aorta | | | | | True lumen | 25.4 ± 12.9 (15, 4.0 - 44.6) | 4.4 ± 4.9 (56, 0 - 17.9) | 4.8 ± 5.9 (71, 0 - 26.7) | | False lumen | 19.2 ± 12.0 (15, 0 - 49.8) | 32.3 ± 4.6 (56, 24.3 - 43.3) | 32.6 ± 5.0 (71, 24.3 - 51.1) | | Total | 44.6 ± 10.9 (15, 29.5 - 64.4) | | | | Just distal to celiac artery origin | | | | | True lumen | 19.8 ± 8.7 (14, 3.6 - 32.6) | 21.5 ± 10.0 (56, 6.2 - 65.9) | 22.3 ± 10.7 (71, 4.0 - 65.9) | | False lumen | 10.0 ± 12.6 (14, 0 - 43.4) | | | | Total | 29.8 ± 8.6 (14, 21.9 - 55.3) | 18.2 ± 8.0 (56, 0 - 34.1) | 18.4 ± 8.9 (71, 0 - 49.8) | | Just distal to SMA origin | | | | | True lumen | 19.2 ± 8.5 (14, 2.6 - 30.2) | 39.6 ± 5.7 (56, 26.8 - 65.9) | 40.7 ± 7.3 (71, 26.8 - 65.9) | | False lumen | 7.4 ± 10.0 (14, 0 - 29.0) | | | | Total | 26.6 ± 5.2 (14, 20.4 - 42.3) | 14.3 ± 6.5 (55, 3.4 - 28.4) | 15.5 ± 7.2 (69, 3.4 - 32.6) | | Just distal to right renal artery origin | | | | | True lumen | 17.4 ± 7.2 (14, 3.1 - 26.1) | 14.3 ± 6.4 (55, 0 - 28.1) | 13.4 ± 8.1 (69, 0 - 43.4) | | False lumen | 5.7 ± 7.6 (14, 0 - 20.1) | | | | Total | 23.2 ± 4.1 (14, 17.2 - 32.0) | 28.6 ± 3.4 (55, 19.5 - 39.4) | 28.9 ± 4.9 (69, 19.5 - 55.3) | | Just distal to left renal artery origin | | | | | True lumen | 17.4 ± 7.6 (14, 2.4 - 26.1) | 15.0 ± 6.6 (53, 2.1 - 26.9) | 15.8 ± 7.2 (67, 2.1 - 30.2) | | False lumen | 5.9 ± 8.1 (14, 0 - 20.5) | | | | Total | 23.3 ± 4.6 (14, 18.0 - 33.6) | 12.2 ± 7.6 (53, 0 - 27.8) | 11.2 ± 8.3 (67, 0 - 29.0) | | Abdominal aorta | | | | | True lumen | 25.0 ± 12.8 (14, 7.4 - 53.0) | 27.1 ± 3.7 (53, 20.0 - 37.9) | 27.0 ± 4.1 (67, 20.0 - 42.3) | | False lumen | 12.3 ± 12.5 (14, 0 - 43.4) | | | | Total | 37.3 ± 11.6 (14, 24.1 - 55.3) | 14.9 ± 6.1 (52, 2.7 - 26.9) | 15.4 ± 6.3 (66, 2.7 - 26.9) | | | | 9.7 ± 6.9 (52, 0 - 29.2) | 8.9 ± 7.2 (66, 0 - 29.2) | | | | 24.6 ± 3.7 (52, 17.2 - 37.9) | 24.3 ± 3.8 (66, 17.2 - 37.9) | | | | 16.5 ± 7.7 (48, 3.8 - 36.3) | 18.4 ± 9.7 (62, 3.8 - 53.0) | | | | 16.1 ± 7.9 (48, 0 - 36.6) | 15.3 ± 9.2 (62, 0 - 43.4) | | | | 32.6 ± 4.9 (48, 24.1 - 44.8) | 33.6 ± 7.2 (62, 24.1 - 55.3) | {27} LCC: left common carotid artery; LSA: left subclavian artery; SMA: superior mesenteric artery; CIA: common iliac artery, PMA P180001: FDA Summary of Safety and Effectiveness Data Page 28 {28} PMA P180001: FDA Summary of Safety and Effectiveness Data # Location of Primary Tear Table 13 reports the location of the primary tear as assessed by the core laboratory. As expected for a study of patients with Type B dissection, the majority of primary tears for the total patient population occurred in the descending thoracic aorta. The distribution in primary tear location appeared to be similar for both patient populations based on core laboratory analysis. Table 13. Location of primary tear per the core laboratory | Location | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stenta | Total | | Aorta at LSA/in LSA | 0% | 1.8% (1/57) | 1.4% (1/72) | | Descending thoracic aorta, distal to LSA | 86.7% (13/15) | 86.0% (49/57) | 86.1% (62/72) | | Aorta at celiac artery/in celiac artery | 0% | 0% | 0% | | Aorta at SMA/in SMA | 0% | 0% | 0% | | Aorta at renal arteries/in renal arteries | 0% | 0% | 0% | | Infrarenal abdominal aorta | 0% | 0% | 0% | | Unknown | 13.3% (2/15) | 12.3% (7/57) | 12.5% (9/72) | LCC: left common carotid artery; LSA: left subclavian artery; SMA: superior mesenteric artery. a Patient 1130090 was unable to be assessed by the core laboratory due to inadequate imaging. # Location of Proximal Extent of Dissection Table 14 provides the distribution of the location of the proximal aspect of dissection as determined by the core laboratory. The majority of the total patient population had the proximal aspect of dissection either at or distal to the LSA, while some patients were noted by the core laboratory to have a dissection with the most proximal aspect in the ascending aorta, aortic arch (proximal to the LCC), or proximal to the LSA (distal to the LCC). Likewise, the majority of patients in both groups had the proximal aspect of the dissection either at or distal to the LSA. Table 14. Location of the proximal aspect of dissection as determined by the core laboratory | Location | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stenta | Total | | Ascending thoracic aorta | 0% | 3.5% (2/57) | 2.8% (2/72) | | Aortic arch, proximal to LCC | 20.0% (3/15) | 1.8% (1/57) | 5.6% (4/72) | | Proximal to LSA, distal to LCC | 6.7% (1/15) | 10.5% (6/57) | 9.7% (7/72) | | Aorta at LSA/in LSA | 20.0% (3/15) | 50.9% (29/57) | 44.4% (32/72) | | Descending thoracic aorta, distal to LSA | 53.3% (8/15) | 31.6% (18/57) | 36.1% (26/72) | | Aorta at celiac artery/in celiac artery | 0% | 0% | 0% | | Aorta at SMA/in SMA | 0% | 0% | 0% | | Aorta at renal arteries | 0% | 0% | 0% | | Infrarenal abdominal aorta | 0% | 0% | 0% | | Unknown | 0% | 1.8% (1/57) | 1.4% (1/72) | LCC: left common carotid artery; LSA: left subclavian artery; SMA: superior mesenteric artery. a Patient 1130090 was unable to be assessed by the core laboratory due to inadequate imaging. Page 29 {29} Location of Distal Extent of Dissection Table 15 provides the distribution of the location of the distal aspect of dissection as determined by the core laboratory. The dissection often extended distally to at least the level of the celiac artery, with the majority of dissections for the total patient population terminating distal to the renal arteries, in either the abdominal aorta or common/external iliac arteries. Compared to the patients who did not receive a Dissection Stent, those patients who did receive a Dissection Stent appeared to more often have a dissection that terminated in the external iliac arteries. Table 15. Location of the most distal aspect of dissection as determined by the core laboratory | Location | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stenta | With Dissection Stentb | Total | | Aorta at celiac artery/in celiac artery | 8.3% (1/12) | 0% | 1.5% (1/68) | | Aorta at SMA/in SMA | 16.7% (2/12) | 3.6% (2/56) | 5.9% (4/68) | | Aorta at renal arteries/in renal arteries | 8.3% (1/12) | 12.5% (7/56) | 11.8% (8/68) | | Infrarenal abdominal aorta | 25.0% (3/12) | 19.6% (11/56) | 20.6% (14/68) | | Common iliac arteries (right or left) | 25.0% (3/12) | 17.9% (10/56) | 19.1% (13/68) | | External iliac arteries (right or left) | 0% | 28.6% (16/56) | 23.5% (16/68) | | Internal iliac arteries (right or left) | 0% | 1.8% (1/56) | 1.5% (1/68) | | Femoral arteries (right or left) | 0% | 0% | 0% | | Unknown | 16.7% (2/12) | 16.1% (9/56) | 16.2% (11/68) | SMA: superior mesenteric artery. a Patients 1130049, 1230003, and 1230007 were unable to be assessed by the core laboratory due to inadequate imaging. b Patients 1130057 and 1130090 were unable to be assessed by the core laboratory due to inadequate imaging. ## Secondary Tears Table 16 provides the distribution of the location of the identified secondary/reentry tears as determined by the core laboratory. The majority of the total patient population presented with secondary tears, often in the descending thoracic aorta as well as in the abdominal aorta and at/near the renal arteries. While most patients in both groups had secondary tears in the descending thoracic aorta, it appeared that patients who received a Dissection Stent had a higher prevalence of secondary tears in the region of the branch vessels (renal arteries, SMA, celiac artery), abdominal aorta, and iliac arteries. Table 16. Location of the secondary/reentry tears as determined by the core laboratory ${}^{a}$ | Location | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stenta | With Dissection Stentb | Total | | None | 13.3% (2/15) | 3.5% (2/57) | 5.6% (4/72) | | Ascending thoracic aorta | 0% | 0% | 0% | | Aortic arch, proximal to LCC | 0% | 0% | 0% | | Proximal to LSA, distal to LCC | 0% | 0% | 0% | | Aorta at LSA/in LSA | 0% | 0% | 0% | PMA P180001: FDA Summary of Safety and Effectiveness Data {30} | Location | Percent Patients (number/total number) | | | | --- | --- | --- | --- | | | Without Dissection Stent | With Dissection Stent | Total | | Descending thoracic aorta, distal to LSA | 80.0% (12/15) | 84.2% (48/57) | 83.3% (60/72) | | Aorta at celiac artery/in celiac artery | 6.7% (1/15) | 28.1% (16/57) | 23.6% (17/72) | | Aorta at SMA/in SMA | 0% (0/15) | 28.1% (16/57) | 22.2% (16/72) | | Aorta at renal arteries/in renal arteries | 13.3% (2/15) | 43.9% (25/57) | 37.5% (27/72) | | Infrarenal abdominal aorta | 13.3% (2/15) | 49.1% (28/57) | 41.7% (30/72) | | Common iliac arteries (right or left) | 0% | 17.5% (10/57) | 13.9% (10/72) | | External iliac arteries (right or left) | 0% | 3.5% (2/57) | 2.8% (2/72) | | Internal iliac arteries (right or left) | 0% | 1.8% (1/57) | 1.4% (1/72) | | Femoral arteries (right or left) | 0% | 0% | 0% | | Unknown | 6.7% (1/15) | 10.5% (6/57) | 9.7% (7/72) | LCC: left common carotid artery; SLA: left subclavian artery; SMA: superior mesenteric artery. a Patients may have presented with multiple secondary/reentry tears. b Patient 1130090 was unable to be assessed by the core laboratory due to inadequate imaging. ## Procedural Information Procedural information is summarized in Table 17. All procedures were performed under general anesthesia. Vascular access techniques employed during the procedure included femoral artery cutdown in 72.6% of patients, percutaneous access in 58.9% of patients, and use of a conduit in 2.7% of patients (multiple access methods were possible). A surgical cutdown appeared more common in patients without a Dissection Stent. Adjunctive techniques for spinal cord protection were performed in 39.7%, including primarily cerebrospinal fluid (CSF) drainage. The majority of patients had either partial or complete coverage of the left subclavian artery (LSA), often without a revascularization procedure. Table 17. Procedural information | Item | Result n (%) | | --- | --- | | Anesthesia Method | | | General | 73 (100%) | | Regional | 0 | | Local | 0 | | | | | Access Method | | | Percutaneous | 43 (58.9%) | | Cut-Down | 53 (72.6%) | | Conduit | 2 (2.7%) | | | | | Adjunctive Techniques to Prevent Paraplegia | | | CSF Drainage | 26 (35.6%) | | Neurologic/Cerebral Monitoring | 2 (2.7%) | | Induced Hypertension | 1 (1.4%) | | | | | LSA Coverage | | | Complete | 28 (38.4%) | | Partial | 15 (20.5%) | PMA P180001: FDA Summary of Safety and Effectiveness Data {31} The mean procedure time was $154.9 \pm 91.3$ minutes and the mean procedural blood loss was $242 \pm 316 \mathrm{ml}$. The mean anesthesia time was $234 \pm 97$ minutes. Procedure times as well as procedural blood loss appeared greater on average in patients who received a Dissection Stent, which is reasonably expected given the differences between groups in terms of number of components placed, as further described below. ## Devices Placed during Index Procedure Tables 18-20 report the number and sizes of Dissection Endovascular Grafts (nontapered and tapered) and Dissection Endovascular Stents placed at the time of the index procedure. The largest (42 mm) and smallest (22 mm) diameters, the longest (218 mm) and shortest (79 mm) lengths, and both tapered options (4 mm and 8 mm) were used among the patients enrolled in the study, supporting the clinical relevance of the available sizes. All available Dissection Stent diameters and lengths were used. Table 18. Number and sizes (diameters and lengths) of nontapered Dissection Endovascular Graft components implanted during index procedure | Diameter (mm) | Length (mm) | N | | --- | --- | --- | | 22 | 79 | 1 | | | 117 | 0 | | 24 | 79 | 0 | | | 117 | 0 | | 26 | 79 | 1 | | | 136 | 2 | | 28 | 82 | 1 | | | 142 | 4 | | | 202 | 1 | | 30 | 82 | 1 | | | 142 | 6 | | | 202 | 2 | | 32 | 82 | 2 | | | 142 | 9 | | | 202 | 5 | | 34 | 79 | 2 | PMA P180001: FDA Summary of Safety and Effectiveness Data Page 32 {32} PMA P180001: FDA Summary of Safety and Effectiveness Data Page 33 | | 154 | 3 | | --- | --- | --- | | | 204 | 7 | | 36 | 79 | 1 | | | 154 | 9 | | | 204 | 3 | | 38 | 79 | 0 | | | 154 | 2 | | | 204 | 3 | | 40 | 83 | 0 | | | 164 | 0 | | | 218 | 1 | | 42 | 83 | 1 | | | 164 | 0 | | | 218 | 1 | Table 19. Number and sizes (diameters and lengths) of tapered Dissection Endovascular Graft components implanted during index procedure | Proximal Diameter (mm) | Distal Diameter (mm) | Length (mm) | N | | --- | --- | --- | --- | | 32 | 28 | 162 | 0 | | | | 202 | 0 | | | 24 | 158 | 0 | | | | 196 | 0 | | 34 | 30 | 159 | 3 | | | | 199 | 5 | | | 26 | 156 | 1 | | | | 194 | 0 | | 36 | 32 | 159 | 2 | | | | 199 | 6 | | | 28 | 159 | 1 | | | | 199 | 1 | | 38 | 34 | 154 | 0 | | | | 204 | 1 | | | 30 | 159 | 1 | | | | 199 | 0 | | 40 | 36 | 160 | 1 | | | | 210 | 3 | | | 32 | 165 | 1 | {33} Table 20. Number and sizes (diameters and lengths) of Dissection Stent components implanted during index procedure | Diameter (mm) | Length (mm) | N | | --- | --- | --- | | 36 | 80 | 13 | | | 120 | 18 | | | 180 | 27 | | 46 | 80 | 3 | | | 120 | 4 | | | 185 | 13 | Table 21 further describes the different main body component combinations used during the initial implant procedure, as selected at the discretion of the treating physician, for patients who did not receive a Dissection Stent and for patients who received a Dissection Stent. All patients received at least one stent-graft, with nearly $80\%$ of patients also receiving at least one Dissection Ste…
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