Biotronik has announced positive 12-month results from the BIOLUX P-I study, demonstrating excellent clinical outcomes for the Biotronik Passeo-18 Lux paclitaxel-eluting balloon. BIOLUX P-I is a randomised controlled study investigating the safety and performance of the Passeo-18 Lux drug-eluting device (n=30), versus an uncoated Passeo-18 angioplasty catheter (n=30), for the treatment of lesions in the femoropopliteal segment up to 200mm in length. Patients were enrolled at five centres in Germany and Austria.
At 12-months, Kaplan-Meier estimates demonstrated a freedom from target lesion revascularisation rate of 84.6% for patients treated with Passeo-18 Lux versus 58.3% of patients treated with an uncoated angioplasty catheter (p=0.064). Furthermore, patients receiving treatment with Passeo-18 Lux demonstrated greater improvement in Rutherford class compared to baseline (72%) versus those receiving treatment with angioplasty (65.2%).
Previously, six-month primary endpoint data, evaluated by an independent core lab, documented significantly reduced angiographic late lumen loss (p=0.038) in the Passeo-18 Lux arm (0.55±0.73mm) versus the uncoated angioplasty catheter (1.07±1.01mm).
Binary restenosis was also reduced (p=0.048) in the Passeo-18 Lux arm versus the uncoated balloon catheter (11.5% vs. 34.6% respectively).
Passeo-18 Lux is a novel treatment for treating de novo and restenotic femoropopliteal lesions. The device is based on the Passeo-18 angioplasty catheter, coated with a matrix of antiproliferative paclitaxel and a biocompatible excipient—enabling an optimal drug transfer to the target lesion tissue. In addition, Passeo-18 Lux features a unique, protective insertion aid to facilitate easier device introduction and handling.
“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 Dierk Scheinert, chief clinical investigator of BIOLUX P-I and Department head, Centre of Vascular Park Hospital, Leipzig, Germany.