Drug-Coated Balloons in Peripheral Artery Disease Michael R. Jaff, DO February 25, 2013

Michael R. Jaff, DO Consultant Abbott Vascular (non-compensated) American Genomics, Inc Becker Venture Services Group Bluegrass Vascular Therapies Cordis Corporation(non-compensated) Covidien (non-compensated) Ekos Corporation (DSMB) Hansen Medical Medtronic (non-compensated) Micell, Incorporated Primacea Trivascular, Inc. Equity Access Closure, Inc Embolitech, Inc Hotspur, Inc Icon Interventional, Inc I.C.Sciences, Inc Janacare, Inc Northwind Medical, Inc. PQ Bypass, Inc Primacea Sadra Medical Sano V, Inc. TMI/Trireme, Inc Vascular Therapies, Inc Board Member VIVA Physicians (Not For Profit 501(c) 3 Organization) www.vivapvd.com

Drug:Device Combinations in PAD Drug Coated Balloons Drug Eluting Stents (?) Bioresorbable Devices

DRUG COATED BALLOONS

Virmani, LINC 2013

Virmani, LINC 2013

Virmani, LINC 2013

Paclitaxel Coated Balloons for Fem/Pop Disease Circulation 2008;118:1358-1365

N Engl J Med 2008;358:689

85 patients (91 cases) with symptomatic femoropopliteal PAD Randomized to Paclitaxel-coated balloon (IN.PACT) (44) vs Bare PTA Balloon (47) Primary endpoint=Late Lumen Loss at 6 months Angiographic core lab adjudicated Circ Cardiovasc Interv 2012;5.

PACIFIER Lesion Characteristics Circ Cardiovasc Interv 2012;5.

Primary Endpoint (LLL @ 6 Months) De Novo vs ISR Occlusion vs Stenosis Lesion Length <10 cm vs >10 cm Circ Cardiovasc Interv 2012;5.

PACIFIER TLR

Circ Cardiovasc Intervent 2012;5:582-9

Binary Restenosis Circ Cardiovasc Intervent 2012;5:582-9 15

Late Lumen Loss Circ Cardiovasc Intervent 2012;5:582-9 16 16

Death Circ Cardiovasc Intervent 2012;5:582-9 17 17 17

104 pts (109 limbs) treated for infrapopliteal disease CLI (82.6%) IC (17.4%) Mean lesion length 17.6 mm (+ 88 mm) 3 month angiographic endpoint JACC 2011;58:1105-9

JACC 2011;58:1105-9

3 month angiographic primary patency 72.6% Limb salvage rate 95.6% 74.2% of ulcers healed at a mean 378 + 65 days JACC 2011;58:1105-9 20

Baseline and Mean 12.5 mo Follow Up JACC 2011;58:1105-9 21

Identified Clinical Trials SIROCCO and STRIDES included in base case, excluded in scenario analysis † only TLR for DES arm available – we combined TLR rates for randomized controlled trial and single arm study; * Conference publication only

Clinical Model Results: Freedom from TLR over 24 Months (pooled) Per visual inspection, the mean TLR rates of DEB, DES, and BMS are substantially lower than PTA Based on weighted pooling taking into account sample sizes of underlying trials/registries.

Clinical Model Results: Freedom from TLR over 24 Months (pooled) STRIDES and SIROCCO excluded Per visual inspection, the mean TLR rates of DEB, DES, and BMS are substantially lower than PTA Based on weighted pooling taking into account sample sizes of underlying trials/registries.

Results: U.S. Budget Impact, 100% Outpatient Medicare Perspective Total charges* for 24 months post index-procedure Facility Provider Perspective Total headroom (APC – device price) for 24 mths PTA BMS DES DEB PTA BMS DES DEB Assumption: DEB reimbursed at PTA rate; DES at BMS rate. * Charges= 2012 Medicare APC Schedule

Results: U.S. Budget Impact, 100% Outpatient STRIDES and SIROCCO excluded Medicare Perspective Total charges* for 24 months post index-procedure Facility Provider Perspective Total headroom (APC – device price) for 24 mths PTA BMS DES DEB PTA BMS DES DEB Assumption: DEB reimbursed at PTA rate; DES at BMS rate. * Charges= 2012 Medicare APC Schedule

Drug-Coated Balloons Expanding body of literature demonstrating efficacy of DCB in peripheral artery disease Potential advantages are great No device remains Opportunities for retreatment if needed Combination therapy (ie atherectomy) appealing Cost-effectiveness emerging