LDDR Geneva, Switzerland February 04, Lewis B. Schwartz, M.D., F.A.C.S.
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1 Bioresorbable scaffolds for peripheral use: Everolimus eluting bioresorbable vascular scaffolds (BVS) for superficial femoral (SFA) and below-the-knee (BTK) arteries LDDR Geneva, Switzerland February 04, 2012 Lewis B. Schwartz, M.D., F.A.C.S.
2 Statement of Disclosure Full-time employee Abbott Laboratories & Abbott Vascular Abbott Park, IL Santa Clara, CA USA Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
3 Bioresorbable Scaffolds- Clinical Studies Device Study Lesions n Outcome Igaki-Tamai PERSEUS SFA 45 50% 6-mos. BEST BTK infrapopliteal 20 90% clinical 3-mos. AMS AMS INSIGHT infrapopliteal 37 68% 6-mos. Schmidt A. Bioabsorbable stents: The Igaki-Tamai Stent Peeters P, Bosiers M, Verbist J, Deloose K, Heublein B. Preliminary results after application of absorbable metal stents in patients with critical limb ischemia. J Endovasc Ther. 2005;12:1-5. Bosiers M, Peeters P, D Archambeau O, Hendriks J, Pilger E, Duber C, et al. AMS INSIGHT - Absorbable metals stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol. 2009;32: Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
4 AMS INSIGHT Bosiers M, Peeters P, D Archambeau O, Hendriks J, Pilger E, Duber C, et al. AMS INSIGHT - Absorbable metals stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis. Cardiovasc Intervent Radiol. 2009;32: Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
5 Patency of the Igaki-Tamai scaffold in the SFA Percent Restenosis IGAKI Kurz > 50% prim. Patency ass. prim. Patency sec. Patency 25% symptomatic Month Schmidt A. Bioabsorbable stents: The Igaki-Tamai Stent Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
6 Absorb Bioresorbable Vascular Scaffold (BVS) Bioresorbable Scaffold Bioresorbable Coating Everolimus XIENCE V Delivery System Poly (L-lactide) (PLLA) Naturally resorbed, fully metabolized Poly (D,L-lactide) (PDLLA) coating Naturally resorbed, fully metabolized Similar dose density and release rate to XIENCE V World-class deliverability All illustrations are artists renditions. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
7 Vascular Response to Coronary BVS 1 month to 4 years: Arterial Integration and Accommodation Absorb BVS Cohort A device 1 month 6 months 1 year 2 years 3 years 4 years Cypher Representative photomicrographs of porcine coronary arteries, 2x Tests performed by and data on file at Abbott Vascular. Photos taken by and on file at Abbott Vascular. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
8 Post-procedure Pre-procedure A B C D E A B C D E
9 A B C D E A B C D E
10 Planned Overlap: OCT (Complete Overlap) Previously published in Eurointervention 2011; 7: (V. Farooq et al.) Post-implantation OCT imaging clearly shows complete overlap with multiple stacked struts identified.
11 % Patients ABSORB Cohort B Cumulative Incidence Curve for Late Loss 100% 90% 80% 70% 0.10 ± 0.23 mm 0.19 ± 0.18 mm 0.85 ± 0.36 mm 60% 50% 40% 30% ABSORB Cohort B (N = 42) Xience DES (N = 23) Vision BMS* (N = 27) 20% 10% 0% In-Stent Late-Loss (mm) Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: Six-month clinical and imaging outcomes. Circ. 2010;122(22): ABSORB is neither approved nor available for sale in the U.S. Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, et al. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: Six-month clinical and imaging outcomes. Circ. 2010;122(22): ABSORB is neither approved nor available for sale in the U.S. *Data from SPIRIT FIRST trial. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
12 ABSORB Cohort B two-year results Pre- ABSORB Immediately Post ABSORB 6 Months 2 Years Ormiston J, Serruys PW. ABSORB Cohort B Trial Two year clinical and angiographic results of the ABSORB everolimus eluting bioresorbable vascular scaffold (poster). Transcatheter Cardiovascular Therapeutics; 2011 November 8; San Francisco, CA. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
13 ABSORB Cohort B two-year angiographic results N=36 Proximal MLD (mm) Inscaffold Distal Post procedure At 6 months At 2 years P value (post-2y) 0.05 < P value (6M-2Y) Late Loss 6M, mm Late Loss 2Y, mm Diameter Stenosis, % Post procedure At 6 months At 2 years P value (post-2y) 0.37 < P value (6M-2Y) Binary restenosis 2y 2.8% (1) 0 0 Ormiston J, Serruys PW. ABSORB Cohort B Trial Two year clinical and angiographic results of the ABSORB everolimus eluting bioresorbable vascular scaffold (poster). Transcatheter Cardiovascular Therapeutics; 2011 November 8; San Francisco, CA. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
14 ABSORB EXTEND Preliminary Data from ABSORB EXTEND: A Report of the 6-month Clinical Outcomes from the First 200 Patients Enrolled Alexandre Abizaid, MD, PhD, FACC Antonio L. Bartorelli MD; Robert Whitbourn MD; Lee Clark PhD; Bernard Chevalier MD; Karine Miquel-Hebert PhD; Xiaolin Li MS; Robert Jan Van Geuns MD, PhD; Didier Carrié MD, PhD; Pieter C. Smits MD, PhD; John A. Ormiston MBChB, PhD; Robert McGreevy PhD; Ashok Seth MD; Patrick W. Serruys MD, PhD on behalf of the ABSORB EXTEND Investigators
15 France Netherlands Italy Israel UK Germany Denmark Switzerland Poland Belgium Spain Australia New Zealand India Hong Kong Japan Malaysia Singapore Brazil Number enrolled 44 sites are open ABSORB EXTEND: Status as of Oct. 17, patients are enrolled, shown by country EMEA (198) ANZ (53) APJ (135) 100 LA (11) Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
16 Note: S is the total number of study scaffolds. Procedural Parameters (All subjects enrolled) Number of Target Lesions (%) EXTEND (N=200) (S=225) 1 lesion subjects lesion subjects 7.0 Planned Overlapping (%) per subject 6.0 Bailout (%) per subject 5.0 with BVS 2.0 metallic DES 3.0 Device Usage (%) per scaffold 3.0 x 18 mm BVS x 28 mm BVS x 18 mm BVS 9.3 Cohort B (N=101) (S=225) NA NA NA
17 ABSORB EXTEND Clinical Outcomes (All subjects enrolled) Non-Hierarchical % (n) 30 Days 6 Months (N=200) (N=200) Cardiac Death % (n) 0.0 (0) 0.5 (1) * Myocardial Infarction % (n) 2.0 (4) 2.0 (4) Q-wave MI 1.0 (2) 1.0 (2) Non Q-wave MI 1.0 (2) 1.0 (2) Ischemia driven TLR % (n) 0.5 (1) 0.5 (1) CABG 0.0 (0) 0.0 (0) PCI 0.5 (1) 0.5 (1) Ischemia driven non-tl TVR % (n) 0.0 (0) 0.5 (1) CABG 0.0 (0) 0.5 (1) PCI 0.0 (0) 0.0 (0) Hierarchical MACE % (n) 2.0 (4) 2.5 (5) Hierarchical TVF % (n) 2.0 (4) 3.0 (6) *A non-bvs was implanted in the target lesion.
18 DESTINY Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, DeLoose K, et al. Randomized comparison of everolimus-eluting vs. bare metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012;55: Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
19 ABSORB BTK Up to two de novo lesions in separate tibial vessels, length < 24 mm, in 90 patients with critical limb ischemia (CLI) ABSORB Bioresorbable Vascular Scaffold (BVS) System 3.0 mm x 28 mm Clinical, duplex Angiography OCT MSCT/ MR Baseline 1mo 6mo 12mo 2yr 3yr Study Objective: Primary Endpoint: First-in-Human study of the safety and performance of the BVS in patients with CLI from occlusive vascular disease of the tibial arteries Freedom from major adverse limb events (major amputation of major reinterventions) occurring with one year or peri-procedural (30-day) death (MALE + POD). Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted. Please add the following as a footnote: ABSORB BTK is neither approved nor available for sale.
20 First case of a drug eluting resorbable scaffold implantation in the peripheral vasculature: ABSORB BTK Peroneal Artery Stenosis Absorb BVS Courtesy, Bosiers M., St. Blasius Hospital, Dendermonde, Belgium Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
21 Restenosis without stent fracture after Profound neointimal hyperplasia after SFA stenting SFA intervention Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
22 Esprit Bioresorbable Vascular Scaffold (BVS) Bioresorbable Scaffold Bioresorbable Coating Everolimus Omnilink Elite Delivery System Poly (L-lactide) (PLLA) Naturally resorbed, fully metabolized Poly (D,L-lactide) (PDLLA) coating Naturally resorbed, fully metabolized Same dose density as Absorb Balloon- Expandable delivery system 035 OTW platform Designed for SFA and Iliac Arteries All illustrations are artists renditions. BVS for SFA and BTK is currently in development at Abbott Vascular. Neither approved nor available for sale. Information contained herein for presentation outside the U.S. and outside Japan only. Not to be reproduced, distributed or excerpted.
23 Porcine iliac model of PVI Hip Extension vs. Flexion Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted.
24 Peripheral Bioresorbable Vascular Scaffold (BVS) Acute implantation in a porcine iliac artery Oversized Nitinol SES BVS
25 Peripheral Bioresorbable Vascular Scaffold (BVS) 6 mos. after implantation in a porcine iliac artery Oversized Nitinol SES BVS
26 ESPRIT I Trial A single de novo lesion in the superficial femoral (SFA) or iliac arteries in patients with symptomatic claudication (Rutherford Becker Category 1-3) Prospective, single arm, multicenter OUS trial evaluating ESPRIT (N=30) One target lesion treated with a single 6.0 x 58 mm ESPRIT Vessel diameter from mm, segment length 50 mm Baseline 1mo 6mo 12mo 2yr 3yr Clinical, Duplex (all subjects) Angiography (all subjects) IVUS (or OCT) Substudy (N ~ 20) MSCT/ MR Substudies (N ~ 5 each) PK Sub Study (N ~ 10, out to 1 mo) Trial Objective: Endpoints: Evaluate safety and performance of the ESPRIT in subjects with symptomatic atherosclerotic disease of the SFA or iliac arteries Procedural, clinical, functional, hemodynamic, angiographic, IVUS, non-invasive imaging in-hospital and at F/U time points indicated Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted. ESPRIT neither approved nor available for sale.
27 ESPRIT I Pre- and post-procedure subtracted angiograms Pre-procedure Post-PTA Post-scaffold Courtesy, Bosiers M., St. Blasius Hospital, Dendermonde, Belgium. Information contained herein for presentation outside the U.S. ONLY. Not to be reproduced, distributed or excerpted
28 ABSORB, ESPRIT, XIENCE V, OMNILINK ELITE and MULTI-LINK VISION are trademarks of the Abbott Group of Companies Igaki-Tamai is a trademark of Igaki Iryo Sekkei Kabushiki Kaisha in the U.S. Cypher is a trademark of Cordis, a Johnson & Johnson Company
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