First US Pulsar-18 stent implanted in BIOFLEX-I clinical trial for the treatment of peripheral arterial disease


On 14 November, Biotronik announced the first US implant of their Pulsar-18 self expanding stent in the BIOFLEX-I investigational device exemption clinical trial. Carlos Mena, Yale University Medical Center, USA, performed the procedure.

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

Performing an entire procedure through a 4F sheath can reduce the risk of patient bleeding and allow them to ambulate more quickly. I am excited to be able to provide these benefits to my patients using an entirely 4F system of tools,” said Mena.

The BIOFLEX-I study is a prospective, non-randomised, multicentre, investigational device exemption 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.

Mark Burket, University of Toledo, USA, 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 4F compatible at lengths up to 200mm 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 4F compatible devices from Biotronik in the lower limbs, or peripheral vascular procedures. Marc Bosiers, chief of Surgery at AZ Sint-Blasius in Dendermonde, Belgium, initiated the 4EVER study, which showed a 12-month primary patency of 81.4% and a 12-month freedom from target lesion revascularisation of 89.3%. The study also showed 100% technical success treating patients with 4F Biotronik devices including the Fortress 4F sheath, Passeo-18 balloon, Cruiser-18 guide wire, and Astron Pulsar and Pulsar-18 stents.