1. 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

2. EPIC Investigators InstitutionPrincipal Investigator Heart Hospital of South DakotaJ. Michael Bachrach, MD Riverside Methodist HospitalGary Ansel, MD Hoag Memorial HospitalS. Myla, MD Trinity Terrace Park HospitalEric Dippel, MD Hahnemann UniversityDaniel McCormick, DO Cardiovascular Center FrankfurtHorst Sievert, MD Bakersfield Heart HospitalBrijesh K. Bahmbi, MD UC Davis Medical CenterJohn Laird, MD Washington Hospital CenterLowell Satler, MD Greenville Hospital SystemBruce Gray, MD Baptist HospitalMalcolm Foster, MD Pinnacle Health HospitalRajesh Dave, MD Ochsner ClinicStephen Ramee, MD St. Elizabeth's HospitalPeter Soukas, MD Covenant Medical CenterFiras Alani, MD Massachusetts General Hospital Christopher Kwolek, MD St. Johns HospitalJeffrey Goldstein, MD Northwestern UniversityJohn Matsumura, MD State University of New York at BuffaloL. N. Hopkins, MD Washington Adventist HospitalMark A. Turco, MD Munroe Regional Medical CenterRobert L. Feldman, MD Heart Hospital of IndianaBrian Bigelow, MD William Beaumont HospitalRobert Safian, MD North Memorial HospitalTroy D. Long, MD Florida HospitalDeepak Vivek, MD Baptist HospitalJames Benenati, MD

3. EPIC Study Design Patients at High-Risk for CEA Prospective, 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

4. 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.

5. EPIC FiberNet ® EPS No delivery system required with a crossing profile 1.7 to 2.9 F Fiber-based filter conforms to asymmetrical vessels Particle entrapment as small as 40 µm

6. EPIC Study Key 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

7. 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

8. EPIC Study Enrollment Criteria Surgical High-Risk Categories One 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

9. EPIC Study Key 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

10. EPIC Study Demographics N = 237 Age in years (mean ± SD)73.9 ± 8.3 Age range (yr)46 - 89 Octogenarian21.1% Male gender62.4% Symptomatic20.3% Diabetes39.7% Current Smoker22.2%

11. EPIC Study High Risk Criteria High RiskN = 237 Clinical Criteria59.6% Anatomical Criteria23.8% Clinical and Anatomical Criteria16.6%

12. EPIC Study Site Reported Lesion Characteristics N = 237 Right Carotid47.7% Lesion Length (mm)17.1 ± 8.8 Lesion Stenosis (%)82.7 ± 8.4 Eccentric Lesion77.0% Calcified Lesion66.1% Ulcerated Lesion34.7% CEA Restenosis21.1%

13. EPIC Study Stent Design Stent*N = 237 Xact36.2% (85/235)** Acculink35.3% (83/235) Precise16.2% (38/235) NexStent7.2% (17/235) Protégé6.4% (15/235) Balloon expandable0.4% (1/235) *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

14. EPIC Study Procedural Results N = 237 Technical success97.5% FiberNet device success94.1% Two wall vessel apposition100% Visible debris captured90.9%

15. EPIC Study 30 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%

16. Primary Endpoint by Age and Symptom Status EPIC Study 30 Day Event Rates

17. All Stroke Clinical Trials Comparison 30 Day Event Rates

18. MACE Clinical Trials Comparison 30 Day Event Rates

19. 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.