BUELACH, Switzerland, November 15, 2012—BIOTRONIK has announced the twelve-month results from the prospective, multicenter, single-arm 4EVER study, which demonstrates the efficacy and safety of BIOTRONIK’s Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.
Twelve-month data for the full cohort showed an impressive 81.4% primary patency rate and a freedom from TLR (target lesion revascularization) rate of 89.3%. The Pulsar-18 subgroup, which had an average lesion length of 10.5 cm, showed a primary patency rate of 73.4% and freedom from TLR rate of 85.2%.
Dr. Marc Bosiers, Chief of Surgery at AZ Sint-Blasius in Dendermonde, Belgium, initiated the study, which investigated both the acute and long-term performance of 4F-compatible devices. The study examined the efficacy of Pulsar stents and the feasibility of treating patients with 4F devices from BIOTRONIK, including the Fortress 4F sheath, Passeo-18 balloon, and Astron Pulsar and Pulsar-18 stents.
“These results are certainly in line with published studies of similar lesion lengths using thick strut, high radial force stents,” said Dr. Koen Deloose, AZ Sint-Blasius in Dendermonde, Belgium. “We generally find that the vast majority of lesions can be treated with Pulsar stents. The fact that the 4EVER study showed 100% technical success in a population where 31% of lesions were calcified—with patency rates and freedom from TLR rates similar to high radial force stents—seems to support this. In fact, analysis of calcified vs. non-calcified lesions showed patency rates of 80.2% and 82.0% respectively with no statistical significant difference. In addition, no clinical data is available that proves whether any currently available self-expanding stent can successfully treat heavily calcified ‘coral reef’ lesions.”
Pulsar stents feature an innovative, highly flexible design coated with PROBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility—which is believed to contribute to the stent’s excellent clinical results. Pulsar-18 is available in diameters from 4–7 mm and lengths from 20–200 mm and deliverable through a 4F sheath. The recently launched Pulsar-35 stent uses the exact same stent technology for use on a 0.035"/6F delivery system.
“The 4EVER results strongly suggest that Pulsar stent systems with optimal radial force combined with high flexibility are superior to systems which concentrate mainly on high radial force in treating SFA disease,” explained Alain Aimonetti, Vice President Sales and Business Development, BIOTRONIK Vascular Intervention. “Our expectations are for an even greater differential in clinical outcomes when the 24-month data are presented. We have invested heavily in clinical studies aimed at providing data to further support Pulsar stents in a variety of clinical settings.”
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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.