BIOLUX P-I is a randomized controlled study investigating the safety and performance of the Passeo-18 Lux Drug Releasing Balloon catheter (n=30), versus an uncoated Passeo-18 PTA catheter (n=30), for the treatment of lesions in the femoropopliteal segment up to 200mm in length. Patients were enrolled at five centers in Germany and Austria.
At 12-months, Kaplan-Meier estimates demonstrated a Freedom from Target Lesion Revascularisation (FTLR) rate of 84.6% for patients treated with Passeo-18 Lux versus 58.3% of patients treated with an uncoated PTA (percutaneous transluminal 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 PTA (65.2%).
Previously, six month primary endpoint data, evaluated by an independent core-lab, documented significantly reduced angiographic late lumen loss (LLL) (p=0.038*) in the Passeo-18 Lux arm (LLL= 0.55 ± 0.73mm) versus the uncoated PTA catheter (LLL= 1.07 ± 1.01mm). Binary restenosis was also reduced (p=0.048*) in the Passeo-18 Lux arm versus the uncoated PTA 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 proven Passeo-18 PTA 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 Prof. Dierk Scheinert, Chief Clinical Investigator of BIOLUX P-I and Department Head, Centre of Vascular Park Hospital, Leipzig, Germany. “This device is very deliverable and easy to use compared with other technologies and treatment options for these demanding vessels.”
“BIOLUX P-I reinforces our confidence in and underlines the clinical efficacy of BIOTRONIK’s Passeo-18 Lux technology”, commented Alain Aimonetti, Vice President of Sales and Business Development, BIOTRONIK Vascular Intervention. “Passeo-18 Lux will be a valuable addition to our product portfolio. Our significant investments in developing outstanding peripheral vascular devices are being translated into real clinical benefits for patients and physicians.”
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market—including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world’s first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. This year BIOTRONIK is celebrating its 50th anniversary.
For more information, visit: www.biotronik.com
Contact:
Manuela Schildwächter
Global Communications Manager
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin
Tel. +49 (0) 30 68905 1466
Email: manuela.schildwaechter@biotronik.com
