Biotronik has completed patient enrolment in the BIOLUX P-I clinical study, which will investigate the use of a drug-eluting balloon catheter to treat peripheral artery disease.

The 60-patient, randomised and controlled study will evaluate the safety and performance of Biotronik Passeo-18 Lux drug-eluting balloon catheter for treating lesions in the femoropopliteal segment compared with an uncoated percutaneous transluminal angioplasty catheter.

Primary endpoint data demonstrating angiographic late lumen loss at six months is expected in the second quarter of 2012.

The Passeo-18 Lux is coated with a homogeneous layer of the paclitaxel, combined with a carrier for increased bioavailability and optimised anti-proliferative effect.