Biotronik Launches Passeo-18 Lux Drug-Releasing Balloon in Europe

January 22, 2014—Biotronik (Lake Oswego, OR) announced the release of its Passeo-18 Lux drug-releasing balloon (DRB) in all countries recognizing CE Mark. The device recently earned European CE Mark approval.

The company stated that the Passeo-18 Lux is a novel combination device for treating de novo and restenotic femoropopliteal lesions. The device’s design is based on the company’s Passeo-18 percutaneous transluminal angioplasty (PTA) catheter, which is coated with a matrix of antiproliferative paclitaxel and a biocompatible excipient that enables an optimal drug transfer to the target lesion tissue. The Passeo-18 Lux includes a novel protective insertion aid to facilitate easier device introduction and handling.

According to Biotronik, the Passeo-18 Lux DRB catheter demonstrated clinical efficacy in the BIOLUX P-I study. Data collected at 6-month and 12-month intervals demonstrated that patients treated with Passeo-18 Lux were less likely to require treatment again. The 12-month data were announced in April 2013.

BIOLUX P-I is a randomized, controlled study investigating the safety and performance of Passeo-18 Lux (n = 30) versus an uncoated Passeo-18 PTA catheter (n = 30) in the treatment of lesions of up to 200 mm in length in the femoropopliteal segment. The primary endpoint is late lumen loss (LLL) in the Passeo-18 Lux arm versus the uncoated PTA catheter arm. Secondary endpoints include the target lesion revascularization rate and the Rutherford classification. The study enrolled patients at six centers in Germany and Austria.

Biotronik reported that 6-month primary endpoint data, evaluated by an independent core lab, previously documented significantly reduced angiographic LLL (P = .038) in the Passeo-18 Lux arm (LLL = 0.55 ± 0.73 mm) versus the uncoated PTA catheter arm (LLL = 1.07 ± 1.01 mm). Binary restenosis was also reduced (P = .048) in the Passeo-18 Lux arm versus the uncoated PTA catheter arm (11.5% vs 34.6%, respectively).

At 12 months, Kaplan-Meier estimates demonstrated an 84.6% rate of freedom from target lesion revascularization for patients treated with Passeo-18 Lux versus 58.3% of patients treated with an uncoated PTA catheter (P = .064). Furthermore, patients treated with Passeo-18 Lux demonstrated greater improvement in Rutherford classification compared to baseline (72%) versus patients treated with PTA (65.2%).

Professor Dierk Scheinert, MD, who is Department Head at the Cardiac Center of Park Hospital in Leipzig, Germany, serves as Chief Clinical Investigator of BIOLUX P-I. In Biotronik’s press release, Prof. Scheinert commented, “Passeo-18 Lux has demonstrated excellent clinical results and supports our growing confidence in DRBs. It is very deliverable and easy to use compared with other technologies and treatment options for these demanding vessels.”