BIOTRONIK Announces First U.S. Pulsar-18 Implant in BIOFLEX-I Investigational Device Exemption (IDE) Clinical Trial
LAKE OSWEGO, Oregon, USA, November 14, 2012 — BIOTRONIK today announced the first U.S. implant of their Pulsar-18 self expanding stent in the BIOFLEX-I IDE clinical trial. Dr. 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 (4F) sheath system, offering a full range of stent diameters of 4-7 mm in lengths from 20-200 mm.
Dr. Mena, 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.”
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 4F 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 4F 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% and a 12-month freedom from TLR (target lesion revascularization) of 89.3%. The study also showed 100% technical success treating patients with 4F devices from BIOTRONIK, including the Fortress 4F sheath, Passeo-18 balloon, Cruiser-18 guide wire, and Astron Pulsar and Pulsar-18 stents.
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.”
Peripheral vascular intervention is a dynamic and evolving field of medicine. The evolution of endovascular therapies continue, driven by physician skills and increasingly complex disease. Extending the realms of minimally invasive treatment requires dedicated, innovative devices and BIOTRONIK is committed to deliver state-of-the-art technologies to improve patient care.
Vascular Intervention Program Director
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About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.