Pantheris System

K212047 · Avinger, Inc. · MCW · Nov 16, 2021 · Cardiovascular

Device Facts

• Record ID: K212047
• Device Name: Pantheris System
• Applicant: Avinger, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Nov 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris System is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Device Story

Pantheris System comprises 7Fr atherectomy catheter, Lightbox Sled, and Lightbox HS Imaging Console. Catheter incorporates optical fiber for real-time OCT imaging of vessel lumen, wall structures, and morphology; used as adjunct to fluoroscopy. Physician operates device in cardiac catheter lab (hospital or office-based) by advancing catheter over 0.014-inch guidewire through vascular sheath to target lesion. Rotating cutter head excises plaque; excised tissue collected in integrated storage segment of cannula. OCT imaging allows physician to visualize vessel and guide atherectomy, potentially improving precision and reducing risk of vessel/stent damage. System provides visual feedback to clinician for procedural decision-making. Benefits include effective plaque removal in native or restenotic peripheral vessels, including ISR, with low adverse event rates.

Clinical Evidence

INSIGHT Trial: prospective, multi-center, single-arm study (n=97). Primary safety endpoint: freedom from MAEs through 30 days (3% rate, 95% upper bound 6.5%, goal <20% met). Primary effectiveness endpoint: technical success (residual stenosis ≤50% post-catheter alone) was 89% (95% CI 82-95%, goal >79% met). Secondary effectiveness: freedom from TLR at 6 months was 93% (95% CI 87-98%, goal >61% met). Procedural success (residual stenosis ≤30% post-adjunctive therapy) was 80%. No evidence of stent damage or adverse effects on arteries reported.

Technological Characteristics

7Fr atherectomy catheter with rotating cutter head and integrated OCT imaging fiber. Working length 110 cm. Materials meet ISO 10993 biocompatibility standards. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Sterilization via e-beam irradiation. Single-use. System includes imaging console and Sled accessory. Software is moderate level of concern.

Indications for Use

Indicated for plaque removal (atherectomy) in partially occluded native or restenotic peripheral vessels, including in-stent restenosis (ISR), with reference diameters 3.0-7.0 mm. Contraindicated for use in iliac, coronary, cerebral, renal, or carotid vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• B-Laser Atherectomy System (K181642)
• Pantheris System (K173862)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 16, 2021

Avinger, Inc. Thomas Lawson VP. Clinical & Regulatory Affairs 400 Chesapeake Drive Redwood City, California 94063

Re: K212047

Trade/Device Name: Pantheris System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW, NQQ Dated: October 6, 2021 Received: October 8, 2021

Dear Thomas Lawson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K212047

Device Name Pantheris System

#### Indications for Use (Describe)

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris System is not in the iliac, coronary, cerebral, renal or carotid vasculature.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> 区 Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K212047

# 510(k) Summary

# General Information

| Submitter | Avinger, Inc. |
|-------------------------|-------------------------------------------------------------------------------|
| Address | 400 Chesapeake Drive<br>Redwood City, CA 94063 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD<br>Director, Clinical & Regulatory Affairs<br>Avinger Inc. |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| Date Prepared | 16 November 2021 |

# Proposed Device

| Trade Name | Pantheris System |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris Catheter |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | MCW, NQQ |
| Regulatory Class | II |

# Predicate Device #1—Primary Predicate Device

| Trade Name | B-Laser Atherectomy System |
|------------------------------------------------------------------------------|-----------------------------------------------|
| Common Name | B-Laser |
| Premarket Notification | K181642 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper |
| Product Code | MCW |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. | |

{4}------------------------------------------------

| Trade Name | Pantheris System |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Pantheris Catheter |
| Premarket Notification | K173862 |
| Regulation Number and<br>Classification Name | 21 CFR§870.4875, Intraluminal Artery Stripper<br>21 CFR§892.1560, Imaging System Optical Coherence<br>Tomography (OCT) |
| Product Code | MCW |
| Regulatory Class | II |
| Note: This predicate device has not been subject to a design-related recall. | |

#### Predicate Device #2-Reference Predicate Device

### Device Description and Proposed Modifications

The Pantheris System consists of a Pantheris atherectomy catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and a Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris atherectomy catheter is a 7 French device with a working length of 110 cm. It incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox via the Sled accessory.

The Pantheris System was reviewed and cleared under K173862. Neither the catheter, the Sled, nor the Lightbox were modified for use in the clinical trial conducted to support this submission and all three elements of the svstem are the same as they were when cleared under K173862.

This Traditional 510(k) is submitted in order to expand the indications for use statement to include in-stent restenosis as a condition for use of the Pantheris catheter.

#### Proposed Indications for Use Statement

The indication for use for Pantheris atherectomy catheter cleared in K173862 is to be modified to include restenotic vessels, including in-stent restenosis (ISR):

The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCTassisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris system is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

{5}------------------------------------------------

### Equivalence of the Subject Device with the Two Predicate Devices

Avinger Inc. has identified the B-Laser Atherectomy System (K181642) as the primary predicate device due to a shared indication to address in-stent restenosis.

The Pantheris catheter is substantially equivalent to the B-Laser Atherectomy System based upon the following similarities:

- · Both devices are intended to be used to address in-stent restenosis in peripheral vessels by atherectomy, under product code MCW;
- · Both devices are used in cardiac catheter labs in either a hospital or an officebased lab:
- · Both devices are advanced to the target in-stent occlusion through an indwelling vascular sheath and over a guide wire;
- Advancement to the target tissue for both devices is monitored by external fluoroscopy imaging; and
- · Both devices have equivalent sizes in terms of outer diameter and working length of the catheter.

The Pantheris 7Fr catheter (subject device) and Pantheris 7Fr catheter (reference predicate device) cleared under K173862 are the exact same device. This predicate device covers specifications, materials, biocompatibility, sterilization, and packaging for the device used in the IDE trial to gather clinical data for ISR treatment.

Table 14.1 shows the comparison of the Pantheris 7 Fr catheter to the predicate devices. The equivalences among these three devices satisfy the criteria for a 510(k) submission.

Table 14.1 Comparison of the Pantheris 7Fr catheter (subject device) to the predicate devices, the Laser-B atherectomy catheter (K181642) and the Pantheris 7Fr catheter (K173862).

{6}------------------------------------------------

| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pantheris<br>Atherectomy System<br>7 French<br>(Avinger, Inc.)<br>(This Submission) | B-Laser<br>Atherectomy<br>System<br>(Eximo Medical<br>Ltd.)<br>K181642 | Pantheris<br>Atherectomy System<br>7 French<br>(Avinger, Inc.)<br>K173862 | |
| Overview | | | |
| Class | II | II | |
| Product Code | MCW NQQ | MCW | |
| Classification<br>Section | 21 CFR §870.4875<br>Intraluminal Artery<br>Stripper | Same | |
| Indication for<br>Use | The Pantheris System<br>is intended to remove<br>plaque (atherectomy)<br>from partially<br>occluded native or<br>restenotic vessels,<br>including in-stent<br>restenosis (ISR), in<br>the peripheral<br>vasculature with a<br>reference diameter of<br>3.0 mm to 7.0 mm,<br>using OCT-assisted<br>orientation and<br>imaging. The system<br>is as an adjunct to<br>fluoroscopy by<br>providing images of<br>vessel lumen, wall<br>structures and vessel<br>morphologies.<br>The Pantheris System<br>is NOT intended for<br>use in the iliac, | The B-Laser<br>Atherectomy<br>System is intended<br>for use in the<br>treatment,<br>including<br>atherectomy, of<br>infra-inguinal<br>stenoses and<br>occlusions,<br>including in-stent<br>restenosis (ISR). | The Pantheris System<br>is intended to remove<br>plaque (atherectomy)<br>from partially<br>occluded vessels in<br>the peripheral<br>vasculature with a<br>reference diameter of<br>3.0 mm to 7.0 mm,<br>using OCT-assisted<br>orientation and<br>imaging. The system<br>is as an adjunct to<br>fluoroscopy by<br>providing images of<br>vessel lumen, wall<br>structures and vessel<br>morphologies.<br>The Pantheris System<br>is NOT intended for<br>use in the iliac,<br>coronary, cerebral,<br>renal or carotid |
| | | MCW NQQ | |
| | | Same | |
| | | | |
| | coronary, cerebral, renal or carotid vasculature. | | vasculature. |
| Intended use | Remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature | Remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature, including in-stent restenosis | Remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature |
| Treatment Method | Atherectomy using a rotating cutter head | Atherectomy with an array of optic fibers surrounded by a circumferential blunt blade | Atherectomy using a rotating cutter head |
| Technical Characteristics | | | |
| Design | System is comprised of (1) catheter, (2) imaging console, and (3) connector between the catheter and the console | System is comprised of (1) catheter, (2) laser console, and (3) connector between the catheter and the console | System is comprised of (1) catheter, (2) imaging console, and (3) connector between the catheter and the console |
| Configuration of the Catheter | A cannula that contains a rotating cutter head and an OCT imaging fiber | A cannula that contains an array of optic fibers surrounded by a circumferential blunt blade | A cannula that contains a rotating cutter head and an OCT imaging fiber |
| Outer Diameter of the Catheter | 2.3 mm (7Fr) | 2.0 and 2.35 mm (6 & X Fr) | 2.3 mm (7 Fr) |
| Working Length of the Catheter | 110 cm | 125 to 150 cm | 110 cm |
| Mechanism of Tissue Excision | Rotating cutter head that cuts the target tissue | Laser pulses for photoablation of the target tissue | Rotating cutter head that cuts the target tissue |
| Excised Tissue Management | Excised tissue is collected and contained in an integrated storage | Excised tissue is collected and removed using vacuum aspiration | Excised tissue is collected and contained in an integrated storage |
| | segment of the<br>cannula | segment of the<br>cannula | |
| Imaging during<br>the procedure | Angiography for<br>initial placement with<br>onboard optical<br>coherence<br>tomography on the<br>cannula | Same | Same |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 | Same | Same |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | Same | Same |
| Laser<br>Classification | Class I | Class IV | Class I |
| Provided Sterile | Yes | Yes | Yes |
| Sterilization<br>Method | e-beam irradiation | Ethylene oxide | e-beam irradiation |
| Sterility<br>Assurance Level | 10-6 | Same | Same |
| Single-use<br>Catheter | Yes | Yes | Yes |
| Packaging | Placed in a tray<br>contained in a Tyvek<br>pouch | Same | Same |
| Clinical<br>Characteristics | | | |
| Anatomical Site<br>of Use in the<br>Body | Peripheral Vessels | Same | Same |
| Clinical<br>Condition | Occluded vessels and<br>vascular stents in the<br>peripheral<br>vasculature | Occluded vessels<br>and vascular stents<br>in the peripheral<br>vasculature | Occluded vessels in<br>the peripheral<br>vasculature |
| Population in<br>which Device is<br>Used | Male or Female<br>Adults | Same | Same |
| Advancement to<br>the Target<br>Tissue | Over an 0.014 inch<br>guide wire through a<br>vascular sheath | Same | Same |
| Sheath<br>Compatibility<br>for the Catheter | 7 Fr | 4 to 7 Fr | 7 Fr |
| Medical<br>Procedure Site | Hospital Cardiac<br>Catheter Lab | Same | Same |
| | Office-based Lab | | |
| Treatment<br>Method | Atherectomy | Same | Same |
| <b>Biological<br/>Characteristics</b> | | | |
| Biocompatibility<br>of Materials<br>Used in the<br>Construction of<br>the Cannula | Meets ISO 10993<br>requirements | Same | Same |
| Length of Time<br>in Contact with<br>the Target<br>Tissue | < 24 hours | Same | Same |

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

# Biocompatibility testing

There have been no new materials or coatings to the Pantheris catheter since review and clearance of K173862, so no new tests were warranted to support this submission. The tests completed and reviewed in K173862 were:

- 1. Sensitization,
- 2. Irritation.
- 3. Systemic toxicity,
- 4. Materials-mediated pyrogenicity,
- 5. Hemocompatibility (dog thrombogenicity),
- 6. Hemocompatibility (platelet and leukocyte PLC with predicate device),
- 7. Cytotoxicity,
- 8. Hemocompatibility (hemolysis direct and indirect),
- 9. Hemocompatibility (complement activation), and
- 10. Hemocompatibility (partial thromboplastin time, human plasma).

{10}------------------------------------------------

#### Electrical safety and electromagnetic compatibility (EMC)

The subject and reference predicate devices comply with IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for electromagnetic compatibility, as reviewed and cleared in K173862.

### Software Verification and Validation Testing

The catheter does not contain any software. The software of the Lightbox component of the system was reviewed and cleared in K173862. The software is considered a "moderate" level of concern, per the FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

### Performance Testing - Bench

Bench testing was conducted to ensure that the Pantheris catheter performs as intended in an ISR model. Following use of the catheter in this model, the stents were evaluated under 20X magnification and there was no evidence of damage to the stents. In addition, the excised tissue was examined and no stent particulate material-was noted to be present when viewed under 20X magnification. No interaction between the Pantheris catheter and the stents during simulated treatment either a single stent or overlapping stent models, which was confirmed by examination of the stents-there was no evidence of cracks, scratches, permanent set or coating delamination.

# Performance Testing - Animal

Preclinical (animal) data were collected from the use of the Pantheris catheter in a simulated ISR model in the pig. Pathologically, acute treatment with the Avinger Pantheris Atherectomy Catheter was associated with no evidence of adverse effects on either the arteries (e.g., no thrombosis or dissection) or the implanted stents (e.g., strut exposure, deformation, or discontinuities/fractures caused by interaction with the cutter), as assessed by light microscopy, radiography, and SEM.

{11}------------------------------------------------

# Performance Testing - Clinical

The INSIGHT Trial was a prospective, multi-center, single-arm trial to determine whether the Pantheris System is substantially equivalent in safety and performance outcomes in the treatment of in-stent restenosis in peripheral vessels.

The primary safety endpoint was defined as freedom from a composite of major adverse events (MAEs) through 30 days after the procedure, as adjudicated by an independent Clinical Events Committee (CEC). The primary effectiveness endpoint was technical success, defined as the percent of target lesions that have a residual diameter stenosis ≤ 50% after use of the Pantheris device alone, as assessed by an independent angiographic core laboratory. The secondary safety endpoint was absence of new or worsening stent fracture following use of the Pantheris catheter. A secondary powered effectiveness endpoint was freedom from target lesion revascularization (TLR) at 6 months following the index procedure. Additional secondary effectiveness included procedural success, defined as the percent of target lesions that have residual diameter stenosis ≤ 30% post-Pantheris and any other adjunctive therapy, as determined by an independent core lab, and changes in Ankle- Brachial Index (ABI), and Rutherford Classes at 30 days and 6 months after the procedure in relation to the measurements prior to the procedure.

A total of 97 subjects were enrolled in the INSIGHT trial, with the treated population consisting of subjects presenting with documented symptomatic in-stent restenosis (stenosis >70% by visual estimation) and who met all eligibility criteria. The target in-stent restenotic lesion had to be located in vessels with diameters of > 3 mm and < 7 mm and not exceed 30 cm in length. Subjects were followed through 30 days and six months postprocedure. The clinical data for 97 subjects enrolled across 17 investigational sites in the USA (n=15) and EU (n=2) who reported for clinic visits 30 days and 85 subjects who reported for clinic visits 6 months after the index procedure were analyzed.

The primary safety endpoint was defined as freedom from a composite of major adverse events (MAEs) through 30 days after the procedure, as adjudicated by an independent Clinical Events Committee (CEC). Only 3 subjects (3%) experienced a MAE, with 97% of subjects from MAEs within 30 days. With only 3% subjects reporting an MAE, with a 95% one-sided upper confidence bound of 6.5%, the primary safety performance goal of MAEs occurring in < 20% of subjects was met.

The secondary safety endpoint was absence of new or worsening stent fracture following use of the Pantheris catheter. Only one (1) catheter inadvertently made contact with a stent during the 97 procedures, a rate of 1%. This endpoint was not established with a sample size requirement, so this performance goal was met not only due to its extremely low incidence rate but also by the experience that after re-training of the one physician who had this event on use of real-time optical coherence tomography imaging during the procedure, he completed 12 cases subsequently with no further events.

{12}------------------------------------------------

The primary effectiveness endpoint of this study was technical success, defined as the percent of target lesions that have a residual diameter stenosis ≤ 50% after use of the Pantheris device alone, as assessed by an independent angiographic core laboratory. In this analysis, 86 out of 97 (89%) subjects had <50% residual stenosis following use of the Pantheris catheter alone, with a 95% one-sided upper confidence bound of 95% and a lower confidence bound of 82%, which met the adjusted performance goal of > 79%.

A secondary powered effectiveness endpoint was freedom from target lession revascularization (TLR) at 6 months following the index procedure. The freedom from TLR of the 85 subjects that have completed their 6-month follow-up visits after the index procedure was 93% (79/85), with a 95% one-sided upper confidence bound of 98% and a lower bound of 87%, which met the performance goal of > 61%.

Additional secondary effectiveness included procedural success, defined as the percent of target lesions that have residual diameter stenosis ≤ 30% post-Pantheris and any other adjunctive therapy, as determined by an independent core lab, and changes in Ankle-Brachial Index (ABI), and Rutherford Classes at 30 days and 6 months after the procedure in relation to the measurements prior to the procedure.

Procedural success was determined if the residual diameter stenosis was ≤ 30% following adjunctive treatment. In this cohort 78 of the 97 subjects (80%) were determined to have a residual stenosis < 30% following review of angiograms by the core lab, with a mean stenosis of 15% ±10.1%.

The ABI measures improved 39% from baseline by the time of the 6-month visit and the Rutherford Classification measures improved by 71% at the same time.

Adjunctive devices used in the procedure were primarily balloons (83%), with balloon angioplasty followed by placement of a stent occurring…