Biotronik’s Pulsar 18 IDE Study Gets First U.S. Patient

In short

On the back of the solid study results we’ve just covered from Biotronik’s European study on use of Pulsar 18 stent in the Superficial Femoral Artery(SFA), the company is now trumpeting news of the first U.S. implant of the device in the BIOFLEX-I IDE clinical trial.

Background

The Pulsar-18 is the newest generation Biotronik peripheral stent, designed specifically for use in the 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 4-7 mm in lengths from 20-200 mm.

The BIOFLEX-I study is a prospective, non-randomised, multi-center, 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).

 Physician comments

Dr. Carlos Mena, from Yale University Medical Center, who performed the endovascular procedure using a 4F sheath, commented, “Performing an entire procedure through a 4F 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 4F system of tools.”

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 4F compatible at lengths up to 200 mm allows us to do that with minimum adverse impact to our patients.”

Company comments

Commenting on the first Pulsar-18 implant of BIOFLEX-I, Dr. Daniel Buehler, President of Biotronik Vascular Intervention, said, “Biotronik is proud to bring the Pulsar-18 stent to U.S. patients. The results of the 4EVER study have validated the 4F treatment approach and shown the Pulsar-18 to be an extremely durable and effective stent.”

Source: Biotronik, Inc.