Biotronik Completes Enrollment in SFA Arm of the BIOFLEX-I Study

July 22, 2014—Biotronik announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of the company’s BIOFLEX-I clinical trial, which is evaluating the use of self-expanding nitinol stents for treating peripheral artery disease. A total of 296 patients were successfully implanted with Biotronik’s Astron Pulsar and Pulsar-18 stents at 34 centers in the United States, Canada, and Europe. The study is being conducted under an investigational device exemption approved by US Food Drug and Administration.

Biotronik stated that the investigational Pulsar-18 self-expanding stent features 4-F introducer sheath compatibility for stent diameters of up to 7 mm and lengths of up to 200 mm for the treatment of lower limb disease. The device provides high bending and axial flexibility. Its sufficient chronic outward force and crush resistance are intended to support the vessel while minimizing the risk of inflammatory response that can be triggered by excessive chronic outward force. Pulsar stents are coated with ProBio, a silicon carbide layer that improves the stent’s hemocompatibility and biocompatibility.

The Pulsar-18 has received European CE Mark approval and is available in more than 50 countries globally. In the United States, the Pulsar-18 is an investigational device limited by law to investigational use.

The BIOFLEX-I trial’s Principal Investigator is Mark W. Burket, MD, of the University of Toledo Medical Center in Toledo, Ohio. In the company’s press release, Dr. Burket commented, “Achieving this enrollment goal in the BIOFLEX-I study brings us one step closer to having these novel products available to US physicians for the treatment of lower limb disease. The Pulsar-18 and Astron stents will give physicians greater opportunity to treat peripheral vascular disease, thereby improving patient quality of life.”

Carlos Mena, MD, of Yale New Haven Hospital in New Haven, Connecticut, was the first United States physician to implant a Pulsar-18 stent through a 4-F sheath. In Biotronik’s press release, Dr. Mena commented, “The ability to deliver an SFA stent through a 4-F sheath expands the possibilities for patient treatment. The flexible Pulsar-18 has a low crossing profile that is advantageous, allowing use not only through the 4-F sheath, but also in tight lesions of the SFA.” 

According to the company, the Pulsar-18 and 4-F approaches to lower limb interventions were validated in several independent studies, including the 4EVER study, which demonstrated the device’s technical success, safety, and efficacy at up to 2 years. 

In December, Marc Bosiers, MD, published the 4EVER results for primary patency at 12 months (73.4%) and 24 months (69.7%) in the Journal of Endovascular Therapy (2013; 20:746–756). Also in the Journal of Endovascular Therapy, Michael Lichtenberg, MD, et al published 12-month results showing a 79.5% primary patency rate for Pulsar-18 in the PEACE I all-comers registry (2014;21:373–380).