The Minvasys Amazonia Pax & Nile Pax Polymer Free Paclitaxel Eluting Stent Program

Transcription

1 The Minvasys Amazonia Pax & Nile Pax Polymer Free Paclitaxel Eluting Stent Program Jean Fajadet, MD, FESC Clinique Pasteur - Toulouse - France

2 Disclosure statement Nothing to disclose

3 Dedicated Delivery Device Dedicated Bifurcation Stent Polymer Free Paclitaxel Abluminal coating on Chromium cobalt platform

4 Chromium Cobalt Alloy Platform Open cell design 78 µ stent thickness

5 Nile Croco Concept

6 Nile Croco OCT Live PCR 2008

7 Nile Croco OCT Live PCR 2008

8 Nile Croco OCT Live PCR 2008

9 Rational behind Pax Technology Polymer Free: To avoid long term lack of endothelization. No additional inflammation due to polymer presence of biodegradation. Abluminal Coating Delivering the drug only onto the arterial wall, nothing washed by the bloodstream. No alteration of the stent mechanical behaviour. Paclitaxel Paclitaxel molecule proprieties allow a polymer free solution. Currently one of the most efficient anti-proliferative agents. One of the most documented safety profiles.

10 Pax Technology Microdrop Spray Crystallization Process

11 Pax Technology Polymer Free Abluminal Paclitaxel Coating Pure Paclitaxel applied using a Microdrop Spray Crystallization Process. Semi-crystalline Paclitaxel stage securing drug integrity & accurate release profile. Consistent coating ensuring at least 98% of drug delivering.

12 Paclitaxel Loading Dose Pax Technology Taxus Liberté Seaquent Please Stent Diameter [mm] Stent Length [mm] Paclitaxel loading [µg/stent] Stent Diameter [mm] Stent Length [mm] Paclitaxel loading [µg/stent] Balloon Diameter [mm] Balloon Length [mm] Paclitaxel loading [µg/balloon]

13 Kinetic release Day 1 40% Day 2 60% Day 8 65% Day 30 95% Day 45 +/- 100% Cumulative % released Back to regular Chromium Cobalt stent within 45 days*. Adapted from : Atherosclerosis 1996;123:17-31 Schwartz RS, chronos NA, and Virmani R. Preclinical Restenosis Models ans Drug- Eluting Stents. Still much to learn JACC (2004);44(7) : Costa MA, and Simon DI. Molecular of Restenosis and Drug-Eluting Stents. Circulation (2005) 111;

14 Coronary Stent Design Ama/Nile Pax Cypher Taxus E Endeavor Xience V Strut Thickness: 73 μm Strut Thickness: 140 μm Strut Thickness: 132 μm Strut Thickness: 91 μm Strut Thickness: 81 μm Coating Thickness: 5 μm Polymer Thickness: 12.6 μm Polymer Thickness: 16 μm Polymer Thickness: 5.3 μm Polymer Thickness: 7.8 μm Total: 78 μm Total: μm Total: 148 μm Total: 96.3 μm Total: 88.8 μm Measurement done counting only the thickness of the polymer on abluminal stent surface²

15 Pax A & Pax B Studies designs Purpose Assess the safety and efficacy of the Amazonia Pax Drug Eluting Coronary Stent System for the treatment of single de novo coronary arteries Amazonia Pax vs Taxus ratio 1/1;n= 30 pts 1 month Amazonia Pax Subset B n= 100 pts Design IVUS OCT - QCA 4 month Subset A: Prospective, randomized, multicenter, active controlled, single blinded. 9 month QCA Subset B: Prospective, non-randomized, multicenter 12 month Primary endpoints Subset A 24 month Percentage of neointimal hyperplasia obstruction by IVUS, OCT and QCA at 4 months 36 month Primary endpoints Subset B 48 month Angiographic in-stent late lumen loss at 9 months 60 month

16 Bipax Study

17 Bipax Study design Purpose Assess the safety and efficacy of the Nile Pax Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation in natives coronary arteries BiPax Clinical Trial n=100 patients 1 month Design Prospective, non-randomized, multicenter trial Primary endpoints Restenosis of the main branch and side branch by an Angiographic Binary Restenosis (ABR) at 9 months. Secondary endpoints In-stent late lumen loss at 9 months Clinically driven MACE (TVF) at 9 months. QCA 6 month 9 month 12 month 24 month 36 month 48 month 60 month

18 Inclusions per center 63 patients included Clinique Pasteur - France 7 patients Centre Cardiologique d Evecquemont - France 7 patients Centre Cardiologique du Nord - France 5 patients Casa di Cura Montevergine - Italy 3 patients Erasmus University - Netherlands 3 patients Instituto Dante Pazzanese de Cardiologia - Brazil 1 patient Tokuda Hospital - Bulgaria 11 patients Clinique Saint Hilaire - France 12 patients Hospital Universitari Vall - Spain D Hebron 14 patients

19 Bipax study population n=60 Nile Pax & Delta Mean age: Female gender : Diabetes : Previous MI : Previous PCI : Stable angina : Silent ischemia : 64 years 27% 27% 18.3% 40% 41.7% 18.3 %

20 Bipax study population Artery 76% 6% 8% MEDINA 0,1,1 1% 1,0,0 3% 0,1,0 12% 0,0,1 0% 1,0,1 6% Side branch involvement: 67% 1,1,0 1,1,1 18% 60%

21 Mr. Per. A. 76 y.o. ACS PCI of LAD-diag. bifurcation, Friday September 18, Clinique Pasteur 7F trans-radial approach

22 7F EBU cath, 2 BMW wires, 3.5x12mm balloon in LAD

23 3.5x2.0 mm NILE-PAX

24 Stent deployed at 18 atm, balloon positionned in diagonal branch

25 Balloon inflated in diagonal branch, followed by kissing balloon

26 Final angiographic result

27 Final angiographic result

28 Procedural data Treatment technique Treatment technique Predilatation Principal Vessel Side Branch 93.4% 45% Kissing-balloon inflations 90% Stent implantation Principal Vessel (study stent) 98.4% Additional stent(s) implanted Principal Vessel Side Branch 21.7% 0% Side 26.7% Single postdilatation Principal Vessel Side Branch 20% 13.4% Dissection during procedure Principal Vessel Side Branch 11.7% 3.4%

29 Rational behind Pax Technology Specific design stent Polymer Free Abluminal Coating Paclitaxel End of patient inclusions : December Results (1 EP) : October 2010