BIOFLEX-I Pivotal Trial Results Presented for Biotronik's Pulsar-18 Stent to Treat SFA Disease
July 5, 2017—Biotronik announced the results of the BIOFLEX-I clinical study and the commercial availability of the company's Pulsar-18 self-expanding stent for the treatment of patients with peripheral artery disease (PAD). The study results were presented during a late-breaking trial session at C3: the 2017 Complex Cardiovascular Catheter Therapeutics Advanced Endovascular and Coronary Intervention Global Summit held June 27–30 in Orlando, Florida.
The Pulsar-18 self-expanding stent with 4-F delivery system was approved in March 2017 by the US Food and Drug Administration (FDA) for the treatment of PAD in the superficial femoral artery (SFA). The device is available in the United States through Biotronik's distribution partner, Getinge.
According to Biotronik, 12-month data from the BIOFLEX-I study demonstrate the safety and efficacy of the self-expanding stent for blocked SFAs. In lesion lengths up to 190 mm, clinical findings demonstrated 99.7% freedom from major adverse events at 30 days, 87.6% freedom from clinically driven target lesion revascularization at 12 months, and 66.8% primary patency at 12 months. Additionally, the BIOFLEX-I study found improved clinical and quality-of-life metrics, including ankle-brachial index, 6-minute walk test, and walking impairment questionnaire.
Mark Burket, MD, who served as the United States Principal Investigator for BIOFLEX-I, commented in Biotronik's announcement, "SFA blockages are often challenging to navigate and treat because of the length of the artery and frequent presence of diffuse disease. Reduced blood flow to the limb can lead to amputation, so it is critical that patients are treated quickly and effectively. Because of Pulsar-18's flexibility, small delivery system, and thin struts, the stenting procedure takes less time, reduces complications, and allows for earlier patient discharge."
Clinical follow-up for the prospective, international, multicenter, two-arm investigational device exemption trial will total 36 months. On the FDA's www.clinicaltrials.gov database, the clinical trial identifiers for the BIOFLEX-I trial are NCT01319812 and NCT01661231.