Biotronik has announced the release of its Passeo-18 Lux drug-eluting balloon in all countries accepting the CE mark, following recent CE approval. The Passeo-18 Lux DRB catheter has shown clinical efficacy in the BIOLUX P-I study. Data collected at six- and 12-month intervals demonstrated that patients treated with Passeo-18 Lux were less likely to require treatment again.
BIOLUX P-I is a randomised, controlled study investigating the safety and performance of Passeo-18 Lux (n=30) versus an uncoated Passeo-18 angioplasty catheter (n=30) in the treatment of lesions in the femoropopliteal segment of up to 200mm in length. The primary endpoint is late lumen loss in the Passeo-18 Lux arm versus the uncoated percutaneous transluminal angioplasty catheter arm. Secondary endpoints include the target lesion revascularisation rate and the Rutherford classification. The study enrolled patients at six centres in Germany and Austria.
Six-month primary endpoint data, evaluated by an independent core lab, previously 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 angioplasty catheter (11.5% vs. 34.6% respectively).
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 classification compared to baseline (72%) versus those receiving treatment with plain angioplasty (65.2%).
“Passeo-18 Lux has demonstrated excellent clinical results and supports our growing confidence in drug-eluting balloons,” said Dierk Scheinert, chief clinical investigator of BIOLUX P-I and Department head, Cardiac Center, Park Hospital, Leipzig, Germany. “It is very deliverable and easy to use compared with other technologies and treatment options for these demanding vessels.”
Passeo-18 Lux is a novel combination device for treating de novo and restenotic femoropopliteal lesions. Its design is based on that of the proven Passeo-18 angioplasty catheter, which is coated with a matrix of anti-proliferative paclitaxel and a biocompatible excipient—enabling an optimal drug transfer to the target lesion tissue. An additional element, however, unique to Passeo-18 Lux, is the novel protective insertion aid to facilitate easier device introduction and handling.
“The release of Passeo-18 Lux is a significant advancement for both physicians and patients, as drug-eluting balloons are emerging as a safe and durable therapy option for lower limb arterial disease,” commented Alain Aimonetti, vice president of Sales and Business Development, Biotronik Vascular Intervention. “Our significant investment in developing outstanding peripheral vascular devices, supported by clinical evidence, is translating into real clinical benefits.”