Biotronik Announces 12-Month 4EVER Results for the Pulsar Stent in SFA

November 15, 2012—Biotronik, Inc. (Lake Oswego, OR) has announced the 12-month results from the prospective, multicenter, single-arm 4EVER study, which demonstrated the efficacy and safety of Biotronik's Pulsar self-expanding stent system in 120 superficial femoral artery patients.

According to the company, the 12-month data for the full cohort showed an 81.4% primary patency rate and a freedom from target lesion revascularization (TLR) 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%.

The study investigated both the acute and long-term performance of 4-F-compatible devices. The study examined the efficacy of the company's Pulsar stents and the feasibility of treating patients with 4-F devices from Biotronik, including the Fortress 4-F sheath, Passeo-18 balloon, and Astron Pulsar and Pulsar-18 stents. Marc Bosiers, MD, of AZ Sint-Blasius in Dendermonde, Belgium, initiated the study and serves as 4EVER's principal investigator. Koen Deloose, MD, also from AZ Sint-Blasius, commented on the findings in the company's press release.

“These results are certainly in line with published studies of similar lesion lengths using thick-strut, high-radial-force stents,” stated Dr. Deloose. “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 versus noncalcified lesions showed patency rates of 80.2% and 82.0% respectively, with no statistical significant difference. In addition, no clinical data are available that prove whether any currently available self-expanding stent can successfully treat heavily calcified ‘coral reef' lesions.”

Biotronik stated that the Pulsar stents feature a flexible design coated with ProBio, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility. Pulsar-18 is available in diameters from 4 to 7 mm and lengths from 20 to 200 mm and is deliverable through a 4-F sheath. The recently launched Pulsar-35 stent uses the same stent technology for use on a 0.035-inch/6-F delivery system.