Clinical Performance of Passeo-18 Lux Confirmed: High Target Lesion Patency Despite High-Risk Patient Group

BUELACH, Switzerland, March 6, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular devices, today announced positive six-month results from the BIOLUX P-II study. The study investigated the performance of the Passeo-18 Lux Drug Releasing Balloon (DRB) in the treatment of vascular occlusions of the lower extremities compared to uncoated PTA (percutaneous transluminal angioplasty) catheters. These data were presented at the Leipzig Interventional Course (LINC) 2014 on behalf of study investigators by Professor Marianne Brodmann, MD, University Clinic Graz, Austria.

The primary clinical endpoint was major adverse event rate or MAE, a composite of all cause death, major amputation of target extremity, Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), and target lesion thrombosis. Despite the high-risk patient population*, the 30-day MAE rate was 0.0 percent in the DRB group compared to 8.3 percent in the PTA group. Six-month primary efficacy endpoint documented a target lesion primary patency rate of 84.3 percent in the DRB group versus 75.9 percent in the PTA group.

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 (below-knee) segment. 36 patients were enrolled in the Passeo-18 Lux arm and 36 patients in the uncoated PTA catheter arm at six centers in Germany, Belgium, and Austria, with Professor Thomas Zeller, MD, University Heart Center, Freiburg Bad Krozingen, Germany, acting as the study’s primary investigator.

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

Passeo-18 Lux is a novel treatment for 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 target lesion tissue. In addition, Passeo-18 Lux features a unique, user-friendly insertion aid, which protects the user and balloon coating from contact and damage.

“The results of BIOLUX P-I and P-II confirm Passeo-18 Lux DRB as a safe and effective therapy option for both above- and below-knee arterial disease,” commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. “Our significant investments in developing outstanding peripheral vascular devices, supported by clinical evidence, improve patients’ quality of life.”

*Over 70 percent of patients taking part in the study were Rutherford Classification of ≥5, many with critical limb ischaemia.

6-month results of the BIOLUX P-II study at a glance


Defined as


Passeo 18-Lux DRB-Group PTA-Group

Primary clinical endpoint



MAE after 30 days


0.0% 8.3%

Efficacy primary endpoint data


TLP after 6 months 84.3% 75.9%
Secondary endpoint Change in Rutherford Classification after 6 months 9 out of 26 patients ranked in class 5 16 out of 26 patients ranked in class 5
Secondary endpoint

Amputation rate after 6 months


3.3% 5.7%

One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5600 employees. Several million heart patients around the world have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring® in 2000, the world’s first 4F compatible 200mm peripheral stent in 2010, Orsiro, the industry’s first hybrid drug-eluting stent, in 2011, and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology in 2012.

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Manuela Schildwächter
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