Twelve-Month Results Support Biotronik's Passeo-18 Lux Paclitaxel-Releasing Balloon

April 11, 2013—Biotronik (Lake Oswego, OR) announced 12-month results from the BIOLUX P-I study of the company's Passeo-18 Lux paclitaxel-releasing balloon.

According to the company, BIOLUX P-I is a randomized controlled study investigating the safety and performance of the Passeo-18 Lux device versus the uncoated Passeo-18 percutaneous transluminal angioplasty (PTA) catheter for the treatment of lesions in the femoropopliteal segment up to 200 mm in length. The study enrolled 60 patients, randomized 1:1, at five centers in Germany and Austria.

Biotronik reported that at 12 months, Kaplan-Meier estimates demonstrated a greater freedom from target lesion revascularization rate with the Passeo-18 Lux compared with the uncoated Passeo-18 PTA catheter (84.6% vs 58.3%; P = .064). Additionally, patients who were treated with Passeo-18 Lux demonstrated greater improvement in Rutherford class compared to baseline versus those receiving treatment with the Paseo-18 PTA catheter (72% vs 65.2%).

The company noted that the 6-month primary endpoint data, which were evaluated by an independent core lab, documented significantly reduced angiographic late lumen loss in the Passeo-18 Lux arm versus the uncoated PTA catheter arm (0.55 ± 0.73 mm vs 1.07 ± 1.01 mm; P = .038). Binary restenosis was also reduced with the Passeo-18 Lux versus the uncoated PTA catheter (11.5% vs 34.6%; P = .048).

“Passeo-18 Lux has demonstrated excellent results in this study and supports our growing confidence in drug-releasing balloons as a viable therapy option for femoropopliteal arterial disease,” commented BIOLUX P-I Chief Clinical Investigator Prof. Dierk Scheinert, MD, in Biotronik's press release. Prof. Scheinert is Department Head of the Center of Vascular Medicine at Park Hospital Leipzig in Germany. “This device is very deliverable and easy to use compared with other technologies and treatment options for these demanding vessels.”