04.08.14
Biotronik SE & Co. KG’s Passeo-18 Lux drug-releasing balloon (DRB) is available in Europe.
According to the company, the Biolux P-I study has confirmed the clinical efficacy of the Passeo-18 product; data collected at six- and 12-month intervals found that patients treated with the DRB were less likely to require treatment again. Biolux P-I is a randomized, controlled study investigating the safety and performance of Passeo-18 Lux (n=30) versus an uncoated Passeo-18 percutaneous transluminal angioplasty (PTA) catheter (n=30) in the treatment of lesions in the femoropopliteal segment of up to 200 mm long. The primary endpoint is late lumen loss in the Passeo-18 Lux arm versus the uncoated PTA catheter arm. Secondary endpoints include the target lesion revascularization rate and the Rutherford classification. The study enrolled patients at six centers in Germany and Austria.
Six-month primary endpoint data, evaluated by an independent core laboratory, previously documented significantly reduced angiographic late lumen loss (LLL) (p=0.038) in the Passeo-18 Lux arm (LLL=0.55 ± 0.73 millimeters) versus the uncoated PTA catheter (LLL= 1.07 ± 1.01 millimeters). Binary restenosis also was reduced (p=0.048) in the Passeo-18 Lux arm versus the uncoated PTA catheter (11.5 percent vs. 34.6 percent respectively).
At 12 months, Kaplan-Meier estimates demonstrated a freedom from TLR rate of 84.6 percent for patients treated with Passeo-18 Lux versus 58.3 percent of patients treated with an uncoated PTA catheter (p=0.064). Furthermore, patients receiving treatment with Passeo-18 Lux demonstrated greater improvement in Rutherford classification compared to baseline (72 percent) versus those receiving treatment with PTA (65.2 percent).
“Passeo-18 Lux has demonstrated excellent clinical results and supports our growing confidence in DRBs,” 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 combination device for treating de novo and restenotic femoropopliteal lesions. Its design is based on that of the Passeo-18 PTA 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 protective insertion aid to facilitate easier device introduction and handling.
“The release of Passeo-18 Lux is a significant advancement, as DRBs are emerging as a safe and durable therapy option for lower limb arterial disease,” said Alain Aimonetti, vice president of sales and business development for Biotronik Vascular Intervention. “Our investment in developing peripheral vascular devices is translating into real clinical benefits.”
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is in Lake Oswego, Ore.
According to the company, the Biolux P-I study has confirmed the clinical efficacy of the Passeo-18 product; data collected at six- and 12-month intervals found that patients treated with the DRB were less likely to require treatment again. Biolux P-I is a randomized, controlled study investigating the safety and performance of Passeo-18 Lux (n=30) versus an uncoated Passeo-18 percutaneous transluminal angioplasty (PTA) catheter (n=30) in the treatment of lesions in the femoropopliteal segment of up to 200 mm long. The primary endpoint is late lumen loss in the Passeo-18 Lux arm versus the uncoated PTA catheter arm. Secondary endpoints include the target lesion revascularization rate and the Rutherford classification. The study enrolled patients at six centers in Germany and Austria.
Six-month primary endpoint data, evaluated by an independent core laboratory, previously documented significantly reduced angiographic late lumen loss (LLL) (p=0.038) in the Passeo-18 Lux arm (LLL=0.55 ± 0.73 millimeters) versus the uncoated PTA catheter (LLL= 1.07 ± 1.01 millimeters). Binary restenosis also was reduced (p=0.048) in the Passeo-18 Lux arm versus the uncoated PTA catheter (11.5 percent vs. 34.6 percent respectively).
At 12 months, Kaplan-Meier estimates demonstrated a freedom from TLR rate of 84.6 percent for patients treated with Passeo-18 Lux versus 58.3 percent of patients treated with an uncoated PTA catheter (p=0.064). Furthermore, patients receiving treatment with Passeo-18 Lux demonstrated greater improvement in Rutherford classification compared to baseline (72 percent) versus those receiving treatment with PTA (65.2 percent).
“Passeo-18 Lux has demonstrated excellent clinical results and supports our growing confidence in DRBs,” 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 combination device for treating de novo and restenotic femoropopliteal lesions. Its design is based on that of the Passeo-18 PTA 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 protective insertion aid to facilitate easier device introduction and handling.
“The release of Passeo-18 Lux is a significant advancement, as DRBs are emerging as a safe and durable therapy option for lower limb arterial disease,” said Alain Aimonetti, vice president of sales and business development for Biotronik Vascular Intervention. “Our investment in developing peripheral vascular devices is translating into real clinical benefits.”
Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is in Lake Oswego, Ore.