Novel Devices Focus – The Path Forward for DEB and New DES and Bioabsorbable Stents Academic View Bruno Scheller, MD Klinische und Experimentelle Interventionelle.

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Presentation transcript:

Novel Devices Focus – The Path Forward for DEB and New DES and Bioabsorbable Stents Academic View Bruno Scheller, MD Klinische und Experimentelle Interventionelle Kardiologie, Universität des Saarlandes, Campus Homburg Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Homburg / Saar, Germany

Bruno Scheller, MD, PhD DISCLOSURES Honoraria B. Braun Vascular Systems, Invatec SRL Grants/Contracted Research B. Braun Vascular Systems Ownership Interest (Stocks, Stock Options or Other Ownership Interest) InnoRa GmbH I intend to reference unlabeled/ unapproved uses of drugs or devices in my presentation. I intend to reference Drug Eluting Ballon, CE-approved but not FDA-approved.

Focus on Drug Coated Balloon – What exists today? Drug Eluting Stent Slow release Persistent exposure ~ 100 - 200 µg dose Polymer Stent mandatory Drug Coated Balloon Immediate release Short-lasting exposure ~ 300 - 600 µg dose No polymers Premounted stent optional Scheller, Circulation 2004; 110: 810-4 Scheller, Heart 2007, 93: 539-41

DEB + stent - porcine coronary model EEE Paclitaxel Ac Paclitaxel Iopromide Circulation 2004; 110: 810-4

Drug Coated Balloon - Pharmacokinetics FreePac - Paclitaxel in coronary artery segments at various time points B. Kelsch, submitted for publication

No aneurisms, even in the high dose groups! Drug Coated Balloon - Dose Finding Histomorphometry – Porcine Coronary Stent Model No aneurisms, even in the high dose groups! B. Kelsch, submitted for publication

Endothelialization and long-term efficacy DEB+BMS (Paccocath coating) vs. DES, porcine coronary model, n=196 Control DEB+BMS Taxus Cypher Endothelialization 3 days follow-up von Willebrand antibody staining Control DEB+BMS Taxus Cypher 28 days follow-up, HE staining Cremers, Eur Heart J 2008; 29 (Suppl): 335

What is currently established, works well in this area - ISR New Engl J Med 2006, 355: 2113-24. Clin Res Cardiol 2008; 97: 779-81. Circulation 2009; 119: 2986-2994

What is currently established, works well in this area - SFA Tepe, N Engl J Med 2008; 358: 689-99. Werk, Circulation 2008; 118: 1358-65

DCB – Unmet Needs and short term Priority FIM data on new coatings Waksman, Circ Cardiovasc Intervent. 2009; 2: 352-8

DCB – Unmet Needs and short term Priority RCT‘s in different Indications – SVD, Bifurcations DCB in Bifurcations – PEPCAD V PEPCAD I, n=118. Clin Res Cardiol 2010; Jan 6. [Epub ahead of print] PEPCAD V, Mathey TCT 2009

DCB – Unmet Needs and short term Priority RCT‘s in different Indications – BTK Schmidt A, LINC 2010

DCB – Long term Priority Combination with a Stent Cypher DEBlue Preliminary data! Hamm, AHA 2009, 14.11.2009, Orlando Pocock, J Am Coll Cardiol 2008; 51: 23-32

DCB – Long term Priority (3-5 years) DCB - Zotarolimus (ABT-578) New Drugs Control DES DEB DCB - Zotarolimus (ABT-578) Cremers, Clin Res Cardiol 2009; 98 (Suppl 1): P415

Succesful and sustainable Platforms in Interventional Cardiology and Angiology Balloon Angioplasty (PTCA and PTA) 1977 Grüntzig 90 - 95% acute success, 3 - 8% acute vessel closure, ~40% repeat revascularization @ 6 months Does NOT prevent acute recoil, remodeling, and neointimal proliferation Bare Metal Stents (Coronary and Certain Peripheral) 1986 Puel, Sigwart 95% + acute success, ~20% repeat revascularization @ 6 months Significantly reduced acute closure issue, prevents acute recoil and negative remodeling; improved initial lumen gain Did NOT prevent, but increases neointimal proliferation Drug Eluting Stents (Coronary Only) 2001 Morice, Serruys, Falotico 95% + acute success, ~10% repeat revascularization @ 6 months Solved acute closure issue, prevents acute recoil and negative remodeling, prevents neotintimal proliferation Drug Coated Balloon (Coronary and Peripheral)