Six-Month Data Presented for Biotronik's Passeo-18 Lux DCB to Treat SFA Disease

January 27, 2016—Biotronik announced that interim 6-month data from the BIOLUX P-III registry evaluating the Passeo-18 Lux drug-coated balloon (DCB) were presented at a symposium during LINC 2016, the Leipzig Interventional Course, being held January 26–29 in Leipzig, Germany. Marianne Brodmann, MD, of the Medical University Graz, Austria, served as Chairperson for the symposium. 

On January 26, Biotronik announced that it had received European CE Mark approval for smaller diameters of the Passeo-18 Lux DCB. The newly available 2- and 2.5-mm sizes are designed to facilitate DCB treatment of below-the-knee arteries with an 0.018-inch platform.  

According to the company, the prospective multicenter BIOLUX P-III Global All-Comers Registry 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. Biotronik announced the beginning of the trial in October 2014.

BIOLUX P-III’s primary endpoint is freedom from major adverse events at 6 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 major adverse events was high at 94.4%, while the rate of freedom from clinically driven TLR was 96.8%.

Gunnar Tepe, MD, the coordinating clinical investigator for the trial, explained in Biotronik’s press release, “Passeo-18 Lux proved its safety in earlier randomized controlled trials for both superficial femoral artery (SFA) and below-the-knee indications. 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,” continued Dr. Tepe, who is with Klinikum Rosenheim in 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 DCBs as a potential standard approach for treating lower limb disease.” 

In addition to the data from BIOLUX P-III, new data on a novel combination therapy approach supporting the Passeo-18 Lux DCB with Pulsar-18 self-expanding stent (SES) were presented. 

The BIOFLEX PEACE all-comers registry, studying the Pulsar SES, reported 6-month interim results for 126 patients. In the study, 55 patients were treated with combination therapy (Pulsar-18 plus DCB) and demonstrated a primary patency rate of 89.1% and a freedom from TLR rate of 90.9%. The company announced the commencement of trial enrollment in July 2014.

The BIOLUX 4EVER clinical trial, which is currently evaluating the outcome of Passeo-18 Lux treatment followed by Pulsar-18 implantation in the SFA, was also presented. Interim 6-month data on 85 patients demonstrated a primary patency rate of 96.1% and a freedom from TLR rate of 98.8%. The company announced the beginning of the trial in July 2014.

In Biotronik’s announcement, Dr. Brodman stated, “Preliminary results from the ongoing BIOFLEX PEACE and BIOLUX 4EVER trials confirm the trend seen in the earlier DEBAS trial. All of them show the high potential of combination therapy with Passeo-18 Lux and Pulsar-18 in the SFA. 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.” In November 2015, Biotronik announced that the 24-month results from the investigator-inititated DEBAS clinical trial were presented at the VEITHsymposium in New York, New York.