Pathway Jetstream G3: A Rotational Flushing and Aspirating Atherectomy System William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine

William A. Gray, MD DISCLOSURES Consulting Fees AccessClosure, Inc., CoAptus, Inc., Mercator MedSystems, Inc., Ovalis, Inc., Paragon Medical, Inc., Pathway Medical Technologies, Inc., Sage Medical, Inc. Grants/Contracted Research Atritech, Inc., Cordis, a Johnson & Johnson company, CREST/ National Institutes of Health, W.L. Gore & Associates, Inc. Ownership Interest (Stocks, Stock Options or Other Ownership Interest) AccessClosure, Inc., CoAptus, Inc., Ovalis, Inc., Paragon Medical, Inc., Pathway Medical Technologies, Inc., Sage Medical, Inc.

Pathway Jetstream G3™ System Jetstream® Catheter Control Pod Console Blades “Down” 2.1 mm Blades “Up” 3.0 mm OTW 135cm Front Cutting, High Speed Rotational Catheter .014GW /7F sheath compatible Differential cutting tip removes all plaque types Aspiration ports collect plaque & thrombus Two sizing options (single device) Integrated system control within the sterile field Rotational Speed One-step size expansion 70K rpm (target therapy speed) Cassette set up and data display outside sterile field 2

Pathway PVD study 1st generation device Purpose: A prospective, single arm, multi-center study to assess performance of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions Drs. Scheinert and Zeller - co-PIs 172 patients at 9 European centers 100% data monitoring Angiographic core lab and CEC adjudicated

Pathway PVD Study Parameter Result Demographics (patients) Mean Age Female (n=88) Male (n=84) 71.9 ± 8.4 years 51.2% 48.8% PVS Treatment Time 3.5 ± 2.4 minutes Core Lab Analysis (lesions) Reference Vessel Diameter n=178 Target Lesion Length n=178 Pre - PVS Diameter Stenosis n=175 Post - PVS Diameter Stenosis n=175 Mean % reduction n=175 3.7 ± 0.8 mm 35.4 ± 25.2 mm 79.1 ± 17.7% 35.6 ± 16.1% 43.5 ± 19.7% Ankle Brachial Index (patients) Baseline n=159 30 days n=149 6 months n=138 12 months n=109 0.59 ± 0.21 0.90 ± 0.23 0.77 + 0.26 0.82 + 0.27 Rutherford Score (patients) Baseline n=169 30 days n=142 3.0 ± 0.9 1.2 ± 1.4 1.5 ± 1.4 1.5 ± 1.3 Parameter Result Major Adverse Events (MAE) within 30 days Death Myocardial Infarction TVR (including TLR) Amputations 0/172 (0%) 0/172 (0%) 0/172 (0%) 2/172 (1.2%) ** Other Device Related Serious Adverse Events within 30 days Emboli Dissection (C/D/E/F) Perforations Abrupt Closure Target Limb Re-intervention 3/172 (1.7%) 1/172 (0.6%) 0/172 (0%) 1/172 (0.6%) 1/172 (0.6%) Target Lesion Revascularization (TLR) within 6 months Freedom from TLR at 6 months Freedom from TLR at 12 months 25/172 (14.5%) 85% 74% * Abbreviations: PVS = Pathway PV System; TVR = Target vessel revascularization; TLR = Target lesion revascularization ** Amputations were planned for both patients prior to the revascularization procedure with the Pathway PV System

Evolutionary changes in Pathway device Proximal Aspiration Port Jetstream G2™ Aspiration Ports Jetstream™

Pathway Jetstream G3™ System G2 NXT Distal Cutter: 10 Flute Design G3 Distal Cutter: 5 Flute Design 54% more efficient at differential cutting compared to Jetstream G2™ NXT* *Calculated in Blades Down (Bench test data on file at Pathway Medical)

**As compared to Jetstream G2™ NXT in bench testing Pathway Jetstream G3™ System 7 French Compatibility Optimized Aspiration* Enhanced Cutting Effectiveness* JETSTREAM G3 Improvements Increased Aspiration Efficiency** 11% Improved differential cutting efficiency (Blades Down)* 54% *As compared to Jetstream G2™ NXT in bench testing in challenging lesion model **As compared to Jetstream G2™ NXT in bench testing Successfully debulk the toughest Calcified lesions with resulting smooth and concentric 4mm lumens Simple treatment of the most challenging CTOs

JETSTREAM G3™ Animation

Pathway Jetstream G3™ System Definitive Therapy for Calcium & CTOs Excellent differential cutting efficiency Optimized Cutting tip Improved torque Front-end cutting Active Aspiration Only atherectomy device with this feature Minimizes risk of distal embolization Short Procedure Times 54% Increase in Cutting Efficiency* Minimal Fluoroscopy /Reduced Lab Time Simplicity of Operation Atherectomy and Thrombectomy indications “Single Device” Solution Multiple Vessel Sizes Expandable Blade Technology Treats disease from SFA to below the knee All Pathologies Atheromatous, Calcium and Thrombus *Compared to Jetstream G2™NXT in Blades Down during bench testing

Comparison of device attributes Calcium Thrombus Embolization Single-sizing Front-cutting FoxHollow ++ CSI + Pathway

Dr. Ivan Casserly: Denver CO November 6, 2009 Jetstream G3™ Runtime: 9:45 mins Right SFA Occlusion Post Jetstream G3™ 1 pass B/D 2 passes B/U 16cm Restenotic chronic total occlusion, crossed with a straight glide wire/glide cath Final after PTA, full balloon expansion at 3 atm’s IC

Dr. Malcolm Foster: Knoxville TN December 15, 2009 Superficial Femoral Artery Jetstream G3™ Runtime: 2:40 mins Post Jetstream G3™ 2 Blades Up Passes Stand alone result 5cm CTO 1 Blades Down Pass IC

IVUS: Concentric 4.0mm lumen Dr. Foster CTO with Jetstream G3™

Calcification

Calcification

After Pathway and 6 mm PTA

Thrombotic occlusion

After Pathway alone

After Pathway and PTA

Conclusions Pathway device adds to the tool set for PAD intervention with the capability to address: Calcification Thrombus-containing lesions ISR Good stand alone results (PTA only) as demonstrated by low rates of stent usage Evolutionary improvements have extended applications, safety and efficacy original device New devices will address larger and smaller vascular needs

Procedural Outcomes 99% device success Mean device activation time = 3:37 minutes 33% of procedures were stand-alone 57% used adjunctive balloon Only 7% require adjunctive stent Please include EBL or aspirate volume