Biotronik has announced completion of enrolment in the BIOLUX P-I – a clinical study investigating the use of a drug-eluting balloon (DEB) catheter, a new approach to treating disease in the more challenging peripheral vascular anatomy.
BIOLUX P-I is a randomised controlled study investigating the safety and performance of Biotronik Passeo-18 Lux, DEB catheter, versus an uncoated percutaneous transluminal angioplasty catheter, for the treatment of lesions in the femoropopliteal segment. Sixty patients were enrolled at five centres in Germany and Austria. Primary endpoint data documenting angiographic late lumen loss at six months is expected in the second quarter of 2012.
“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 Dierk Scheinert, primary investigator of BIOLUX P-I and head of Angiology, 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 randomised 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 optimised antiproliferative effect. The drug-carrier combination has already demonstrated early clinical efficacy in the recently presented first-in-man study PEPPER (Paclitaxel releasing balloon in patients presenting with in-stent restenosis), investigating Biotronik’s Pantera Lux DEB in coronary in-stent restenosis.
“BIOLUX P-I is an important study in our comprehensive DEB clinical programme, and aims to provide level one evidence in support of our proprietary ‘Lux’ drug coating technology,” commented Alain Aimonetti, vice president of Sales and Marketing, Biotronik Vascular Intervention.