Biotronik Announces First U.S. Pulsar-18 Implant in BIOFLEX-I IDE Clinical Trial


January 16, 2013
Biotronik BIOFLEX-I IDE Clinical Trial Puslar-18 Peripheral Artery Disease

January 16, 2013 — Biotronik announced the first U.S. implant of their Pulsar-18 self expanding stent in the BIOFLEX-I IDE clinical trial. Carlos Mena of Yale University Medical Center performed the procedure.

The Pulsar-18 is the newest generation Biotronik peripheral stent, designed specifically for use in the superficial femoral artery (SFA). The Pulsar-18 features optimized radial force and extended lengths for the treatment of difficult femoral disease. The Pulsar-18 is fully compatible with a 4-French  sheath system, offering a full range of stent diameters of 4-7 mm in lengths from 20-200 mm.

Mena, who performed the endovascular procedure using a 4 French sheath, commented, “Performing an entire procedure through a 4 French sheath can reduce the risk of patient bleeding and allow them to ambulate more quickly. I’m excited to be able to provide these benefits to my patients using an entirely 4 French system of tools.”

The BIOFLEX-I study is a prospective, non-randomized, multi-center, Investigational Device Exemption (IDE) trial being performed in the United States, Europe and Canada. The study will evaluate the safety and efficacy of the Astron and Pulsar stent families for the treatment of peripheral arterial disease. The primary endpoints of the BIOFLEX-I clinical trial are 12-month primary patency, 30-day and 12-month freedom from major adverse events (MAEs).

Mark Burket, M.D., from the University of Toledo and National Principal Investigator of BIOFLEX-I, said, “The addition of the Pulsar-18 to the BIOFLEX-I study will allow us to treat longer lesions with a single stent, rather than overlapping shorter stents. This reflects the reality of SFA disease. The fact that the Pulsar-18 is still 4 French compatible at lengths up to 200 mm allows us to do that with minimum adverse impact to our patients.”

The news of the first BIOFLEX-I Pulsar-18 implant follows the recently presented 12-month results of the European 4EVER study, which investigated both the acute and long-term performance of 4 French compatible devices from Biotronik in the lower limbs, or peripheral vascular procedures. Marc Bosiers, M.D., chief of surgery at AZ Sint-Blasius in Dendermonde, Belgium, initiated the 4EVER study, which showed a 12-month primary patency of 81.4 percent and a 12-month freedom from TLR (target lesion revascularization) of 89.3 percent. The study also showed 100 percent technical success treating patients with 4 French devices from Biotronik, including the Fortress 4 French sheath, Passeo-18 balloon, Cruiser-18 guide wire, and Astron Pulsar and Pulsar-18 stents.

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