Drug Coated Balloons Future Directions and Development of
Drug Coated Balloons Future Directions and Development of DCB Systems Bruno Scheller Klinische und Experimentelle Interventionelle Kardiologie, Universität des Saarlandes, Campus Homburg Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes Homburg / Saar, Germany
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company • Grant/Research Support • B. Braun, Angioscore • Speaker Honoraria • B. Braun, Invatec Medtronic • Major Stock Shareholder/Equity • Inno. Ra Gmb. H (a small company doing research in local drug delivery) • Intellectual Property Rights • Named as coinventor of a patent application submitted by Charite university hospital, Berlin, Germany
Clinical evidence – existing technology RCT o Coronary ISR +++ o SFA de-novo and restenosis +++ o Coronary de-novo with BMS ++/- o Dialysis shunts + o Coronary BMS mounted on DCB - Non-randomized data o BTK long lesions + o ISR intracranial + o Coronary de-novo small vessels +/- o Coronary bifurcation +/- o … Not all drug coated balloon catheters are equally effective Need for RCT for different coatings in different indications
Future Directions and Development of DCB Systems Technical improvements of existing PTX technology o Deliverability o Reduced drug loss o Particles (clinically relevant? ) o Tissue kinetics (amorphous vs. crystalline)
Prototype Drug Coated Balloon non-coated Paccocath coated
Speck, Circulation: Cardiovasc Int 2012, submitted
Histopathology of the myocardium revealed slightly more vasculitis and localized myocardial scar in animals treated with DCSC; findings were slight or mild with no pronounced dose dependency. Unpublished data
PACCOCATH Technology Proposed Mechanism of Action Juan Granada, TCT 2009
Future Directions and Development of DCB Systems Technical improvements of existing PTX technology o Deliverability o Reduced drug loss o Particles (clinically relevant? ) o Tissue kinetics (amorphous vs. crystalline) Indication and Vascular territory o Optimal dose? o Dedicated coatings?
Kelsch, Invest Radiol. 2011; 46: 255 -63
Primary endpoint (late lumen loss in-segment) PTCA Uncoated balloon PACCOCATHTM PTA uncoated (control) PACCOCATHTM 0. 74 ± 0. 86 mm 0. 03 ± 0. 48 mm 1. 7 ± 1. 8 mm 0. 4 ± 1. 2 mm New Engl J Med 2006, 355: 2113 -24 New Engl J Med 2008; 358: 689 -99
Vajda, Am J Neuroradiol 2011
Future Directions and Development of DCB Systems Technical improvements of existing PTX technology o Deliverability o Reduced drug loss o Particles (clinically relevant? ) o Tissue kinetics (amorphous vs. crystalline) Indication and Vascular territory o Optimal dose? o Dedicated coatings? Reduced need for stents o Dedicated devices o ‘DEBonly’ concept
Drug Coated Angio. Sculpt Presentation of Gary Gershony
Mathey, Euro. Intervention 2011; 7: K 125 -8
occluded CX, stenotic PL 1 CX after angioplasty dissection Bare metal stent 2. 5 / 13 mm Se. Quent Please 2. 5 / 30 mm final result 3 months Se. Quent Please 2. 5 / 20 mm
SQP bifurcation - 48 yrs male SQP 2. 5 30 SQP 2. 5 15 13 months SQP 2. 5 20
Euro. Intervention 2011; 7: K 17 -22
Directions and Development of DCB Systems Clinical Evidence Technical improvements of existing PTX technology Dedicated devices ‘DEBonly’ concept New drugs
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