Enrollment Begins for BIOFLEX PEACE Registry of Biotronik's Pulsar-18 Stent

July 10, 2014—Biotronik announced the start of enrollment and first Pulsar-18 stent implantations in the investigator-initiated BIOFLEX PEACE study. The all-comers registry is designed to evaluate the Pulsar-18’s efficacy for interventions on femoropopliteal lesions in a larger group of patients in a real-world setting. The study will build on the positive results for the device in the earlier 4EVER and PEACE trials.

Biotronik stated that the highly flexible Pulsar stents are coated with ProBio, a silicon carbide layer intended to improve the stent’s hemocompatibility and biocompatibility. Pulsar-18 is available in diameters of 4 to 7 mm and lengths of 20 to 200 mm, all deliverable through a 4-F sheath.

According to the company, the BIOFLEX PEACE all-comers registry is a prospective, single-arm, multicenter study that will investigate the Pulsar-18 4-F stent for the treatment of femoropopliteal atherosclerotic lesions, following patients out to 24 months. Primary endpoints are major adverse events at 6 months and primary patency at 12 months. Secondary endpoints include clinical success (defined as improvement by one or more Rutherford class), target lesion revascularization (TLR), and amputation rate, along with improvement in pain rating score and walking impairment. Extensive subgroup analyses are planned, including lesion location, lesion preparation prior to stenting, and stent oversizing.

The BIOFLEX PEACE study’s lead investigator is Michael Lichtenberg, MD, of the Vascular Center Clinic in Arnsberg, Germany. Dr. Lichtenberg commented in the company’s press release, “Following up on the successful PEACE I study, which reported a primary patency rate of 79.5% and a freedom from TLR rate of 81%, BIOFLEX PEACE will enroll up to 500 patients to evaluate the safety and efficacy of Pulsar stents in a real-world setting. This extensive cohort will allow subgroup analyses of different treatment strategies—including lesion preparation, the importance of correct stent sizing and spot stenting, amongst others—with the goal of assessing the efficacy of these respective approaches.”