Six-Month BIOLUX P-II Data Reported for Biotronik's Passeo-18 Lux DRB

March 6, 2014—Biotronik (Lake Oswego, OR) announced positive 6-month results from the BIOLUX P-II study, which investigated the performance of the company’s Passeo-18 Lux drug-releasing balloon (DRB) in the treatment of vascular occlusions of the lower extremities compared to percutaneous transluminal angioplasty (PTA) with uncoated catheters. Prof. Marianne Brodmann, MD, of the University Clinic Graz in Graz, Austria, presented the data at LINC 2014: the Leipzig Interventional Course, which was held January 28–31, 2014 in Leipzig, Germany.

Prof. Brodmann commented in Biotronik’s press release, “Passeo-18 Lux has demonstrated excellent clinical results in 
BIOLUX P-II and supports our confidence in DRBs as an infrapopliteal therapy option. The results show once again that there is no ‘class effect’ with DRBs and that each device behaves differently.” 

According to Biotronik, BIOLUX P-II is a randomized, controlled, multicenter study investigating the performance of the Passeo-18 Lux DRB compared to an uncoated Passeo-18 PTA catheter in the treatment of lesions in the infrapopliteal segment. The BIOLUX P-II study’s primary clinical endpoint is the rate of major adverse events (MAEs). MAEs are defined as a composite of all-cause death, major amputation of the target extremity, target lesion revascularization, target vessel revascularization, and target lesion thrombosis.

The BIOLUX P-II study’s primary investigator is Prof. Thomas Zeller, MD, of the University Heart Center in Freiburg Bad Krozingen, Germany. Study investigators enrolled 36 patients in the Passeo-18 Lux arm and 36 patients in the uncoated PTA catheter arm at six centers in Germany, Belgium, and Austria. The study was composed of a high-risk population: more than 70% of patients had a Rutherford classification of ≥ 5, and many had critical limb ischemia.

Biotronik reported that despite the study’s high-risk patient population, the 30-day MAE rate was 0% in the DRB group compared to 8.3% in the PTA group. For the 6-month primary efficacy endpoint, the target lesion primary patency rate was 84.3% in the DRB group versus 75.9% in the PTA group.

Secondary endpoints at 6 months were the change in Rutherford classification and the amputation rate. In the Passeo-18 Lux DRB group, nine of 26 patients had a Rutherford classification of 5 versus 16 of 26 patients in the PTA group. The amputation rate was 3.3% in the DRB group versus 5.7% in the PTA group.

The Passeo-18 Lux is a novel treatment for de novo and restenotic femoropopliteal lesions. The device is based on the company’s Passeo-18 PTA catheter and is coated with a matrix of antiproliferative paclitaxel and a biocompatible excipient, enabling drug transfer to target lesion tissue. The Passeo-18 Lux also features a user-friendly insertion aid that protects the user and balloon coating from contact and damage, advised Biotronik.