Biotronik has reported the positive six-month results from the BIOLUX P-II study, a randomized, controlled multicenter study designed to investigate the performance of the Passeo-18 Lux DRB compared to an uncoated Passeo-18 PTA catheter in the treatment of lesions in the infrapopliteal (below-knee) segment.

Scientists presented the findings at the Leipzig Interventional Course 2014 conference.

The primary clinical endpoint was major adverse event rate or MAE, a composite of all cause death, major amputation of target extremity, Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), and target lesion thrombosis.

Despite the high-risk patient population, the 30-day MAE rate was 0.0% in the DRB group compared to 8.3% in the PTA group.

Six-month primary efficacy endpoint documented a target lesion primary patency rate of 84.3% in the DRB group versus 75.9% in the PTA group.

Passeo-18 Lux is a novel treatment for de novo and restenotic femoropopliteal lesions.

The device is based on the proven Passeo-18 PTA catheter, coated with a matrix of antiproliferative paclitaxel and a biocompatible excipient — enabling an optimal drug transfer to target lesion tissue.

In addition, Passeo-18 Lux features a unique, user-friendly insertion aid, which protects the user and balloon coating from contact and damage.

Biotronik Vascular Intervention vice president of marketing Dr. Alexander Uhl said the results of BIOLUX P-I and P-II confirm Passeo-18 Lux DRB as a safe and effective therapy option for both above- and below-knee arterial disease.

"Our significant investments in developing outstanding peripheral vascular devices, supported by clinical evidence, improve patients’ quality of life," Dr Uhl added.