EPIC Trial

Evaluating the Use of the FiberNet® Embolic Protection System In

Carotid Artery Stenting

Subbarao Myla, MD FACC

Principal Investigator & Medical Director CV Research and Vascular Intervention

Hoag Memorial Hospital

on behalf of

Co-Principal Investigator J. Michael Bacharach, MD FACC

and the EPIC investigators

EPIC InvestigatorsInstitution Principal Investigator

Heart Hospital of South Dakota J. Michael Bachrach, MDRiverside Methodist Hospital Gary Ansel, MDHoag Memorial Hospital S. Myla, MDTrinity Terrace Park Hospital Eric Dippel, MDHahnemann University Daniel McCormick, DOCardiovascular Center Frankfurt Horst Sievert, MDBakersfield Heart Hospital Brijesh K. Bahmbi, MDUC Davis Medical Center John Laird, MDWashington Hospital Center Lowell Satler, MDGreenville Hospital System Bruce Gray, MDBaptist Hospital Malcolm Foster, MDPinnacle Health Hospital Rajesh Dave, MDOchsner Clinic Stephen Ramee, MDSt. Elizabeth's Hospital Peter Soukas, MDCovenant Medical Center Firas Alani, MDMassachusetts General Hospital Christopher Kwolek, MDSt. Johns Hospital Jeffrey Goldstein, MDNorthwestern University John Matsumura, MDState University of New York at Buffalo L. N. Hopkins, MDWashington Adventist Hospital Mark A. Turco, MDMunroe Regional Medical Center Robert L. Feldman, MDHeart Hospital of Indiana Brian Bigelow, MDWilliam Beaumont Hospital Robert Safian, MDNorth Memorial Hospital Troy D. Long, MDFlorida Hospital Deepak Vivek, MDBaptist Hospital James Benenati, MD

EPIC Study Design

Patients at High-Risk for CEAProspective, Multi-center, Non Randomized Trial

Evaluating the FiberNet® Embolic Protection System for Use During Carotid Artery Stenting Procedures

(26 Sites)

N = 237

Follow Up - 30 Days

Primary Endpoints Adjudicated by Independent Clinical Events Committee

EPIC FiberNet Embolic Protection System

FiberNet®

system is a novel EPD that incorporates the ability to allow flow during the procedure (filter), capability to capture small particles (occlusion

balloon) and has deliverability of standard coronary guidewire.

EPIC FiberNet® EPS

No delivery system required with a crossing profile1.7 to 2.9 F

Fiber-based filter conforms to asymmetrical vessels

Particle entrapment as small as 40 µm

EPIC StudyKey Endpoints

• Primary Endpoint Composite rate of death, stroke and MI at

30 Days

• Secondary Endpoints Death, stroke, and MI rates Non-stroke neurological events Device success, technical success and

procedural success rate

EPIC Study Inclusion Criteria

• Symptomatic ≥ 50% stenosis

• Asymptomatic ≥ 70% stenosis

• Target lesion: ICA, CCA or ICA/CCA bifurcation

• Target vessel diameter: 2.5 - 7.0 mm

EPIC Study Enrollment CriteriaSurgical High-Risk CategoriesOne or More Criteria Required in Either Category

Clinical Criteria

Age > 75

CCS Class III/IV or Unstable Angina

CHF (NYHA Class III/IV)

LVEF < 35%

Prior MI within 2-6 weeks

Current CAD with ≥ 2 vessel disease

Severe pulmonary disease

Dialysis dependant renal failure

Planned CABG or valve replacement

Anatomical Criteria

Contralateral occlusion

CEA re-stenosis

Low infraclavicular lesion

Tandem lesion ≥ 70%

Laryngeal nerve palsy

Previous neck radiation, tracheostomy/stoma

Cervical immobility

High cervical lesion at or above C2

EPIC StudyKey Exclusion Criteria

• Planned treatment of contralateral carotid within 30 days

• Stroke within 14 days or TIA within 48 hours

• MI within 14 days

• Total occlusion

• Stenosis unsuitable for carotid stenting

• Serial lesions that require more than one stent

EPIC Study Demographics

N = 237

Age in years (mean ± SD) 73.9 ± 8.3

Age range (yr) 46 - 89

Octogenarian 21.1%

Male gender 62.4%

Symptomatic 20.3%

Diabetes 39.7%

Current Smoker 22.2%

EPIC Study High Risk Criteria

High Risk N = 237

Clinical Criteria 59.6%

Anatomical Criteria 23.8%

Clinical and Anatomical Criteria 16.6%

EPIC Study Site Reported Lesion Characteristics

N = 237

Right Carotid 47.7%

Lesion Length (mm) 17.1 ± 8.8

Lesion Stenosis (%) 82.7 ± 8.4

Eccentric Lesion 77.0%

Calcified Lesion 66.1%

Ulcerated Lesion 34.7%

CEA Restenosis 21.1%

EPIC Study Stent Design

Stent* N = 237

Xact 36.2% (85/235)**

Acculink 35.3% (83/235)

Precise 16.2% (38/235)

NexStent 7.2% (17/235)

Protégé 6.4% (15/235)

Balloon expandable 0.4% (1/235)

*Some patients had multiple types of stents implanted thus % do not sum to 100%*Some patients had multiple types of stents implanted thus % do not sum to 100%** Numbers based on the 235 patients treated with a carotid stent** Numbers based on the 235 patients treated with a carotid stent

EPIC Study Procedural Results

N = 237

Technical success 97.5%

FiberNet device success 94.1%

Two wall vessel apposition 100%

Visible debris captured 90.9%

EPIC Study30 Day Event Rates

Endpoint All death = 0.4% All stroke = 2.1%

• Major Stroke = 1.3%

• Minor Stroke = 0.8%

All MI = 0.9%

30 Day Composite Primary Endpoint = 3.0%

Primary Endpoint by Age and Symptom Status

1.6%2.7%

1.1%

6.3%

4.2% 4.2%

8.2%

1.6%

0%

2%

4%

6%

8%

10%

Age < 80 Age ≥ 80 Symptomatic Asymptomatic

30-Day Stroke 30-Day Composite Endpoint

EPIC Study 30 Day Event Rates

4.8% 4.4% 4.0%3.4%

2.1%

4.9%

6.9%

5.5% 5.4%

0%

2%

4%

6%

8%

10%All Stroke Clinical Trials Comparison

30 Day Event Rates

6.2%5.6% 5.3%

3.9%3.0%

6.9%7.5%

8.3% 8.6%

0%

2%

4%

6%

8%

10%MACE Clinical Trials Comparison

30 Day Event Rates

EPIC Study Conclusions

The EPIC study reveals very low stroke, MI & death rates using a novel embolic protection system during Carotid stenting with commercial stents.

The unique Filter design with low porosity and ease of use features combined with aspiration prior to retrieval led to low event rates.

The FDA OPC are clearly met for the FiberNet Embolic protection system in a prospective multi-center single arm study.