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NOTHING MUCH CHANGED SINCE 2012 THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Why INTEREST in BTK Lesions “Real-World” lesions in SEA “Real-World” impact for SEA patients THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 60-70% of PVD work is BTK 20-30% at At Ankle 1st Presentation is Tissue Loss Long healing time is required THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 A Schmidt et al Catheter Cardiovas Intervent 2010 58 CLI patients 62 limbs Mean lesion length 183mm Re-stenosis > 50% after months 68.8% THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Fernandez et al J Vas Surg 2010:52 834-42 111 CLI patients year follow up Duplex patency 33% Re-intervention rate 50% stenosis at months BTK POBA BTK DEB 69% 27% Medtronic, Inc 8200 Coral Sea Street NE Mounds View, MN 55112 www.medtronic.com Urgent Field Safety Notice IN.PACT® Amphirion DrugEluting Balloon (DEB) November, 2013 Medtronic reference # FA597 Dear Healthcare Professional (Hospital Administrator, OR Manager, and Risk Manager), Based on data from the IN.PACT® DEEP clinical study, Medtronic has decided to voluntarily recall and stop selling the IN.PACT Amphirion drug-eluting balloon THE 151HNATIONAL CONGRESS (DEB) Only the IN.PACT Amphirion DEB is subject to OF CARDIOLOGY 2016 IN.PACT DEEP Randomized Trial Zeller et al J Am Coll Cardio 2014 Oct Multicenter Prospective 2:1 DEB : POBA 358 CLI patients End-points CD-TLR LLL THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 CD-TLR DEB 9.2% POBA 13.1% p=0.291 LLL DEB 0.61 +/- 0.78mm p=0.950 POBA 0.62 +/- 0.78mm A safety signal driven by major amputations through the IA-DEB arm versus the 12 months was observed in PTA arm (8.8% vs 3.6%; p = 0.080) THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 MEANWHILE IN SINGAPORE 2010-2012 THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Tan Tock Seng Hospital Registry 2010 Loong TH etal 24 patients agreed to the use of DEB DEB use after predilatation with uncoated balloon Patients that need DES or BMS stent salvage not included in analysis All started on double antiplatelets for at least months At ankle and below ankle cases included as well THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Safety– Acute Re-Thrombosis Limb Salvage Month Month Month Patency by Duplex THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 DEB Use in BTK Lesions Age Range 45-94 Mean 67.6 Males 12 ( 57%) Females (43%) DM 19 (90%) HPT 16 (76%) Hyperlipidaemia 13 (62%) IHD (38%) Smoking (10%) patients passed away > 30 days after intervention from unrelated causes 19 patients BKA- ascending infection, vessel patent THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Mean lesion length 140mm Percentage of > 50% re- stenosis on duplex Months 0% Months 10% Months 20% THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 100 \ 90 \ 80 ' 60 50 \ I \ -+- \ \ 40 \ DEB Angioplasty with 20 10 Angioplasty \ , \ ' I "' } I "' I "' I I I DEBATE-BTK Liistro et al Circulation 2013 Single Center DM CLI patient 1:1 Randomisation DEB:POBA 132 patients Primary End-point Binary Stenosis on treated segment 12 months on US or Angiography Secondary End Points CD TLR, Amputations and Occlusion THE 151HNATIONAL CONGRESS OF CARDIOLOGY 2016 Binary restenosis 27% DEB TLR 18% DEB vs Occlusion 17% DEB Only major vs 74% POBA p