LINC 2016: Studies Highlight Efficacy of BIOTRONIK Passeo-18 Lux Drug-Coated Balloon in Superficial Femoral Artery Disease

LEIPZIG, Germany, and BUELACH, Switzerland, January 27 2016– BIOTRONIK, a global leader in cardio- and endovascular medical technology, presented new data regarding the Passeo-18 Lux drug-coated balloon (DCB) in a scientific symposium at LINC 2016. During the symposium, which focused on data emerging from Passeo-18 Lux’s rigorous clinical program, interim six-month data from the BIOLUX P-III registry was released for the first time. The prospective multicenter all-comers study is designed to provide further evidence for Passeo-18 Lux’s efficacy in treating peripheral artery disease in routine clinical practice; it is enrolling a minimum of 700 patients at 55 sites in 19 countries in Europe, Asia, Australia and the Pacific.

“Passeo-18 Lux proved its safety in earlier randomized, controlled trials for both superficial femoral artery (SFA) and below-the-knee (BTK) indications1,2. As these trials served as proof of concept for the technology, the next step was to extend these results in a population reflecting routine clinical practice. BIOLUX P-III is therefore an all-comers registry enrolling a large number of real-world patients,” commented coordinating clinical investigator for the trial Dr. Gunnar Tepe, Rosenheim Clinic, Germany. “The results seen in the small cohort of patients from earlier trials are now strengthened by an interim analysis of 200 patients, offering further support for DCB as a potential standard approach for treating lower limb disease.”

BIOLUX P-III’s primary endpoint is freedom from major adverse events (MAE) at six months, defined as a composite of freedom from mortality, major target limb amputation and target lesion revascularization (TLR). Of the 200 patients for whom data is available so far, the rate of freedom from MAE was high at 94.4% while the rate of freedom from clinically driven TLR was 96.8%.

In addition to the data from BIOLUX P-III, new data on a novel combination therapy approach supporting Passeo-18 Lux DCB with Pulsar-18 self-expanding stent (SES) was presented. The BIOFLEX PEACE all-comers registry, studying the Pulsar SES, reported six-month interim results for 126 patients. 55 patients were treated with combination therapy (Pulsar-18 plus DCB) and demonstrated a Primary Patency (PP) rate of 89.1% and a freedom from TLR rate of 90.9%. Furthermore, the BIOLUX 4EVER clinical trial, which is currently evaluating the outcome of Passeo-18 Lux treatment followed by Pulsar-18 implementation in the SFA, was also presented. Interim six-month data on 85 patients demonstrated a PP rate of 96.1% and a freedom from TLR rate of 98.8%.

“Preliminary results from the ongoing BIOFLEX PEACE and BIOLUX 4EVER trials confirm the trend seen in the earlier DEBAS trial3. All of them show the high potential of combination therapy with Passeo-18 Lux and Pulsar-18 in the SFA,” stated the symposium’s chairperson Dr. Marianne Brodmann, Graz Medical University, Austria. “These preliminary results indicate that combination therapy supporting Passeo-18 Lux DCB with the thin-strut Pulsar-18 SES may improve the treatment outcomes of the two individual technologies in challenging vessel morphologies and patient populations.”

“Passeo-18 Lux and Pulsar-18, which is now also available in 2.0 and 2.5 mm diameters, represent key technologies in the BIOTRONIK peripheral portfolio, each bringing unique clinical benefits,” commented Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “We stand by their clinical proof as individual treatment options, and with these additional studies we hope to extend the highly encouraging 24 month results from the DEBAS trial, demonstrating that combination therapy with both devices can achieve even better clinical performance.”

1. ^{Scheinert D, et al. J Endovasc Ther .2015, 2(22)}
   
2. ^{Zeller T, et al. JACC CardiovascInterv.2015, 8(12)}
   
3. ^{Mwipatayi P. Self-Expanding Thin Strut Nitinol Stents (Pulsar) Plus DEBs: 2-Year Results from The DEBAS Trial Are Promising. Presented at: Veith Symposium; November 19, 2015. ClinicalTrials.gov: NCT0187935}