BIOTRONIK has announced the completion of enrollment in their BIOLUX P-I European clinical study. The study is investigating the safety and efficacy of the Passeo-18 Lux drug-eluting balloon catheter for the treatment of peripheral vascular disease.
Angiographic data on lumen size will be used to assess its impact on restenosis at the primary endpoint of 6 months and results are expected in the second quarter of 2012.
From the press release:
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.
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.