1. 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

2. 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.

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

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

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

6. 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

7. 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

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

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

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

11. 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

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

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

14. 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

15. Succesful and sustainable Platforms in Interventional Cardiology and Angiology
Balloon Angioplasty (PTCA and PTA)
1977 Grüntzig
% acute success, 3 - 8% acute vessel closure, ~40% repeat 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 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 6 months
Solved acute closure issue, prevents acute recoil and negative remodeling, prevents neotintimal proliferation
Drug Coated Balloon (Coronary and Peripheral)