1400_Waksman_C_Mon

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Published on December 10, 2008

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Absorbable Metal Stent, Clinical Update and DREAMS – Drug Eluting Absorbable Metal Stent, Concept and pre-clinical data : Absorbable Metal Stent, Clinical Update and DREAMS – Drug Eluting Absorbable Metal Stent, Concept and pre-clinical data Ron Waksman, MD Professor of Medicine (Cardiology) Georgetown University, Associate Director Division of Cardiology Washington Hospital Center Washington DC ICI Tel-Aviv Israel Potential Advantages of a Bioabsorbable Non-polymer Based Coronary Stent : 2 Potential Advantages of a Bioabsorbable Non-polymer Based Coronary Stent Provides metal stent scaffolding and radial strength properties Leaves no stent behind (no chronic inflammation, no long-term impact on local vasomotion) No “Full metal jacket”  easier surgical bypass connection No Stent Thrombosis No Need for Prolonged antiplatelet therapy MRI / CT compatibility  provides non-invasive F/U Absorbable Magnesium Stent* : 3 * Investigational device only - not for sale - FEA: Crimped state FEA: Fully expanded state Absorbable Magnesium Stent* Absorbable Magnesium Stent : 4 ~ 4 weeks ~ 8 weeks Performs like a bare metal stent (BMS) Radial strength, recoil parameters similar to BMS Naturally bioabsorbs Absorbable Magnesium Stent Magnesium Alloy & Biocompatibility : 5 Magnesium absorbable alloy 316L stent 54% reduction in neointima formation after 56 days Minipigs - 8 weeks after implantation* Magnesium Alloy & Biocompatibility Magnesium Alloy & Absorption : 6 Heublein et al. Magnesium alloy absorption 56 days after implantation in domestic pigs Magnesium Alloy & Absorption Complete occlusion of the left pulmonary artery after de-banding and closure of the arterial duct with a clip (the device with three markers is for calibration purposes) : 7 Complete occlusion of the left pulmonary artery after de-banding and closure of the arterial duct with a clip (the device with three markers is for calibration purposes) Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany Crossing the stenosis with a guide wire angiography revealed reperfusion : 8 Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany Crossing the stenosis with a guide wire angiography revealed reperfusion Implantation procedure of Mg Stent 3.0/10mm with a contrast filled balloon catheter : 9 Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany Implantation procedure of Mg Stent 3.0/10mm with a contrast filled balloon catheter At one week follow up after Mg Stent the left lung was reperfused : 10 Peter Zartner, M. D., Pediatric CardiologyUniversity of Erlangen-Nuremberg, Germany At one week follow up after Mg Stent the left lung was reperfused Clinical Results : 11 Clinical Results BEST-BTK First in Man experience with the Biotronik absorbablE metal StenT Below The Knee 20 CLI patients (Rutherford 4-5) with BTK pathology Implants performed between December ‘03 – January ‘04 Patient demographics (N=20) : 12 Male 10 50% Female 10 50% Average age 76 yrs (59 - 96) Clinical vascular status Rutherford Class IV 9 45% Rutherford Class V 11 55% Patient demographics (N=20) Lesion description (N=20) : 13 Lesion description (N=20) Average lesion length 11 mm (2 mm – 20 mm) Average vessel diameter 2.7mm (2.5 mm 3 mm) Average stenosis 84 % (75% – 95%) Dissection 0 0% Ulceration 1 5% Thrombus 3 15% Calcification 14 70% Procedure description : 14 Procedure description Cross-over (11/20) Inflow improving R/ Long sheath in popliteal Lesion crossing wire .014” Procedure description : 15 Procedure description Post-PTA control Flow restricitive residual stenosis PTA Expleo – Biotronik Procedure description : 16 Procedure description Post operative control Satisfactory outflow Stenting AMS – Biotronik 94.7% Limb Salvage After One Year : 17 94.7% Limb Salvage After One Year Limb Salvage Rate Time (Days) Bosiers M, Dendermonde, Belgium; Peeters P, Bonheiden, Belgium 3M 100.0% 6M 94.7% 9M 94.7% 12M 94.7% High Patency Rate Below The Knee : 18 High Patency Rate Below The Knee Primary Clinical Patency Time (Days) Bosiers M, Dendermonde, Belgium; Peeters P, Bonheiden, Belgium 3M 89.5% 6M 84.2% 9M 78.9% 12M 72.4% Early Prototypes for “big AMS” : 19 Early Prototypes for “big AMS” 8mm BE AMS 8mm SE AMS First in Man Coronary: PROGRESS-AMS Study : First in Man Coronary: PROGRESS-AMS Study Clinical Performance and Angiographic Results of the Coronary Stenting with Absorbable Metal Stents PROGRESS AMSCenters & Investigators : 21 Australia M. Horrigan, Melbourne Belgium B. de Bruyne & W. Wijns, Aalst Germany R. Erbel & M. Haude, Essen The Netherlands JJRM. Bonnier & J. Koolen, Eindhoven Switzerland F. Eberli & T. Luescher, Zurich P. Erne, Luzern UK C. Di Mario & C. Ilsley, London USA R. Waksman, Washington PROGRESS AMSCenters & Investigators PROGRESS AMS Hypothesis & Study Endpoint : 22 Primary Hypothesis Demonstrate feasibility and safety in the range of currently available bare metal stent systems with a MACE rate after 4 months < 30%. Primary Endpoint MACE at 4 months defined as: Cardiac death Nonfatal myocardial infarction Ischemia driven TLR PROGRESS AMS Hypothesis & Study Endpoint PROGRESS AMSSecondary Endpoints : 23 PROGRESS AMSSecondary Endpoints Device success (defined as final diameter stenosis by QCA) Procedure success (defined as final diameter stenosis without in hospital MACE) Process of degradation Late in lesion lumen loss at 4 months (QCA/IVUS) Percent diameter stenosis at 4 months (QCA/IVUS) Binary restenosis at 4 months (QCA/IVUS) MACE at 6 and 12 months TLR at 4, 6, and 12 months TVR at 4, 6, and 12 months 50% 50% PROGRESS AMS Major Inclusion Criteria : 24 PROGRESS AMS Major Inclusion Criteria Patient ≥ 18 years of age Evidence of ischemia (stable or unstable angina, or a positive functional ischemia study) Planned single de novo lesion treatment in a native coronary artery Target vessel 3.0 to 3.5 mm in diameter by visual estimate Lesion length < 15 mm in length Target lesion in a native coronary artery with ≥ 50% and < 100% diameter stenosis Patient has normal baseline CK / CK-MB / Troponin I values PROGRESS AMSDemographics : 25 PROGRESS AMSDemographics PROGRESS AMSLesion Location/Characteristics : 26 PROGRESS AMSLesion Location/Characteristics * Visual Estimate PROGRESS AMS Angioplasty Procedure : 27 PROGRESS AMS Angioplasty Procedure PROGRESS AMSIn Hospital, 30d and 4m events : 28 PROGRESS AMSIn Hospital, 30d and 4m events Primary Endpoint 30-Day In Hospital 4-Month C.R. ♀ 39 years – RCA : 29 C.R. ♀ 39 years – RCA POST Follow-UP IVUS – Atlantis SR Pro 40 MHz AMS: 16-row MSCT Compatible : 30 Bare Metal Stent Absorbable Metal Stent Lind et al Heart 91:1604, 2005 AMS: 16-row MSCT Compatible PROGRESS AMSIVUS : 31 Plaque Vessel QCU-Software, MEDIS, Leiden, Holland Lumen PROGRESS AMSIVUS Results IVUS-analysis PROGRESS AMS : 32 Negative remodeling / recoil ‘Extra-stent’ neointima ‘Intra-stent’ neointima 42% 13.5% 41% Contribution to lumen loss ∑ = 96.5% Results IVUS-analysis PROGRESS AMS PROGRESS AMSTLR rates : 33 0 20 40 60 80 100 0 30 60 90 120 150 180 210 240 270 300 330 Days Post Intervention iTLR Occurrence PROGRESS AMSTLR rates 4-month ANGIO PROGRESS AMSStudy Conclusions : 34 PROGRESS AMSStudy Conclusions The FIM coronary study showed: Feasibility: High technical and procedural success Safety: no death, no MI, no stent thrombosis The study met the primary endpoint (MACE <30%) Further improvement in stent design, coating and combination with antiproliferative drugs are the focus of the present R&D efforts to further improve efficacy for coronary use The Absorbable Metal Stent (AMS): The AMS technology platform is proven MRI / CT compatible Absorption was documented with IVUS during FU DREAMS – Drug Eluting Absorbable Metal Stent (AMS) : 35 The Problems: Early recoil Fast degradation Neointima formation The Solutions: Change stent Design Modify the Alloy Load a drug with Bioabsorbable Polymer The Outcome: Drug Eluting Absorbable Metal Stent (DREAMS) DREAMS – Drug Eluting Absorbable Metal Stent (AMS) BIOTRONIK DREAMS Pimecrolimus-Eluting Stent System : 36 Stent: Bioabsorbable Magnesium Alloy Discrete Drug Delivery Reservoirs Drug: Pimecrolimus Carrier: Bioresorbable Matrix Modifications BIOTRONIK DREAMS Pimecrolimus-Eluting Stent System Next generation coronary AMS : 37 Current coronary AMS is currently improved by ... Prolonged mechanical stability Surface passivation Modified Alloy Improved stent design Reduction of neointima hyperplasia DREAMS (Drug elution) Goal: Continue human trials with improved AMS early 2007 Animal feasibility trial ongoing Next steps of AMS improvement in preparation Next generation coronary AMS Slide 38: 38 Mechanism of Action: Pimecrolimus Dose Finding Angiography: Percent Area Stenosis : 39 Dose Finding Angiography: Percent Area Stenosis Pimecrolimus Preliminary Results from Pre clinical Studies : 40 5w histology Pimecrolimus group > 5w histology bare metal group < Pimecrolimus Preliminary Results from Pre clinical Studies Future DevelopmentsDrug Eluting Absorbable Metal Stent DREAMS : 41 * = Animal data available at Biotronik / ** = In vitro data available at Biotronik Future DevelopmentsDrug Eluting Absorbable Metal Stent DREAMS Absorbable Metal Stent Platform Fully absorbable platform Proven biocompatibility throughout the entire absorption process* Effective scaffolding properties** Controlled Drug Eluting Stent Design Precise drug release kinetic and direction Resorbable polymer Status of AMS 2006 : 42 Safe in human coronaries Safe in peripheral arteries (tibial) Absorbed as intended < 90 days Long term animal studies available No distal embolization, No inflammation Fully compatible with CT or MRI angiography Restenosis mainly due to early recoil and neointima formation New Generations AMS under preclinical testing Status of AMS 2006 Slide 43: 43 Thank You

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