Enrollment complete in BIOTRONIK 4EVER clinical trial for treatment of peripheral vascular disease

BIOTRONIK announced today that the full cohort of 120 patients has been successfully enrolled into the physician-initiated 4EVER clinical study. Follow up is scheduled at 1, 6 and 12 months, with immediate and 6 month results potentially available in January 2012.

4EVER is a prospective, non-randomized, multicenter, clinical investigation evaluating the safety and efficacy of the Astron Pulsar and Pulsar-18 stents in the SFA. The primary endpoint is primary patency at 12 months. Two of the secondary endpoints are procedural success and wound complication rate.

"The 4EVER study aims to demonstrate the efficacy of Astron Pulsar and Pulsar-18 stents implanted in SFA lesions up to 200mm in length, and secondarily, the technical feasibility and potential safety benefits of lower limb intervention using only 4F devices," commented Dr. Marc Bosiers, Vascular Surgeon, Dendermonde, Belgium, principal investigator of 4EVER. He continued, "Several studies have demonstrated lower wound complication rates of 4F vs. 6F vascular access in coronary applications, and it is anticipated that 4EVER will confirm these findings in the peripheral application."

Alain Aimonetti, Vice President of Sales and Marketing for Vascular Intervention at BIOTRONIK, added, "Increasing numbers of endovascular practitioners are realizing the benefits of 4F intervention—not just in terms of lower device crossing profile and reduced wound complications, but also the potential cost savings related to faster ambulation and reduced usage of vascular closure devices."

In recent years, BIOTRONIK has launched the industry's broadest portfolio of low-profile, 4F introducer-sheath-compatible devices aimed at putting the right tools in the hands of peripheral interventionalists. This has positioned BIOTRONIK at the forefront of vascular device innovation—with highlights including the world's first fully 4F compatible, 200mm self-expanding stent, Pulsar-18.

BIOTRONIK will continue to drive innovative, minimally invasive solutions for physicians treating lower limb arterial disease. During 2011, further enhancements to the PTA portfolio will be launched, including longer balloon lengths in the successful Passeo-18 PTA range and Passeo-14, a dedicated 0.014"-based infrapopliteal PTA balloon. In addition, the optimized stent design of Pulsar-18 will be released in 20-80mm lengths, bringing higher radial force and even greater flexibility compared to previous generation devices.