BUELACH, Switzerland, May 21, 2012 – Six-month results from the BIOLUX P-I study, demonstrating excellent safety and efficacy results for the BIOTRONIK Passeo-18 Lux Paclitaxel Releasing Balloon, were presented on Thursday, May 17, 2012, at the EuroPCR 2012 congress by Dr. Andrej Schmidt, Chief Angiologist at Herzzentrum/Park- Krankenhaus, Leipzig, Germany.
The Passeo-18 Lux Paclitaxel Releasing Balloon is a novel approach for treating de novo and restenotic femoropopliteal lesions. The device is based on the proven Passeo-18 percutaneous transluminal angioplasty (PTA) catheter, which is then coated with a matrix of proven antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate (BTHC) 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.
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 200 mm in length. Patients were enrolled at five centers in Germany and Austria.
Primary endpoint data evaluated by an independent core-lab documented significantly reduced angiographic late lumen loss (LLL) at 6 months (p = 0.033) in the Passeo-18 Lux arm (in-segment LLL = 0.51 ± 0.72 mm) vs. the uncoated PTA catheter (in-segment LLL = 1.04 ± 1.00 mm). Binary restenosis was also reduced (p = 0.048) in the Passeo-18 Lux arm vs. the uncoated PTA catheter (11.5% vs. 34.6% respectively).
“The Passeo-18 Lux has demonstrated excellent results in this study and reinforces our 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, Herzzenturm/Park-Krankenhaus 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 again demonstrates improved clinical outcomes with our Lux drug-releasing balloon technology,” remarked Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. “We have invested heavily in delivering state-of-the-art peripheral vascular devices and a supportive clinical study program. Passeo-18 Lux will be an exciting and proven addition to our unique portfolio.”
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.
More information: www.biotronik.com