BIOTRONIK, a leading European manufacturer of therapy solutions for vascular intervention, announced the completion of enrollment in the BIOLUX P-I - a clinical study investigating the use of a drug-eluting balloon (DEB) catheter, a promising new approach to treating disease in the more challenging peripheral vascular anatomy.
BIOLUX P-I is a randomized controlled study investigating the safety and performance of BIOTRONIK Passeo-18 Lux, DEB catheter, versus an uncoated percutaneous transluminal angioplasty (PTA) catheter, for the treatment of lesions in the femoropopliteal segment. Sixty patients were enrolled at five centers in Germany and Austria. Primary endpoint data documenting angiographic late lumen loss (LLL) at six months is expected in the second quarter of 2012.
Drug-eluting balloons (DEBs) are emerging as an effective and durable treatment option for treating patients with de novo and restenotic arterial disease in the lower limbs. Restenosis following treatment with standard PTA balloons is a significant issue, and it is anticipated that delivery of a drug to the lesion location could significantly improve therapy efficacy.
"Drug-eluting balloons are one of the most exciting technological developments in recent years, and based on early clinical experience there is a lot of interest and promise for this new treatment option", commented Professor Dierk Scheinert, primary investigator of BIOLUX P-I and Head of Angiology Dept, Herzzentrum/Park Hospital, Leipzig, Germany. "However, it is vital that efficacy and safety data are provided for each commercially available DEB, as outcomes may be greatly influenced by drug and coating formulations - we expect that the randomized BIOLUX P-I study will generate the positive level one clinical data that we require to confidently provide more efficacious therapy."
The Passeo-18 Lux is coated with a homogeneous layer of the well-substantiated drug Paclitaxel combined with a carrier for increased bioavailability and optimized antiproliferative effect. The drug-carrier combination has already demonstrated early clinical efficacy in the recently presented first-in-man study "PEPPER", investigating BIOTRONIK's Pantera Lux DEB in coronary in-stent restenosis.
"BIOTRONIK is committed to bringing proven, high quality therapies to patients with vascular disease," commented Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. "Our significant investment in clinical research continues to demonstrate BIOTRONIK's dedication to leading the industry in finding solutions for improved patient outcomes. BIOLUX P-I is an important study in our comprehensive DEB clinical program, and aims to provide level one evidence in support of our proprietary 'Lux' drug coating technology".
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