Biotronik announced on 28 June 2011 that the full cohort of 120 patients has been successfully enrolled into the physician-initiated 4EVER clinical study. Follow-up is scheduled at one, six and 12 months, with immediate and six-month results potentially available in January 2012.
4EVER is a prospective, non-randomised, multicentre, clinical investigation evaluating the safety and efficacy of the Astron Pulsar and Pulsar-18 stents in the superficial femoral artery. 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 superficial femoral artery lesions up to 200mm in length, and secondarily, the technical feasibility and potential safety benefits of lower limb intervention using only 4F devices,” said 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 realising 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.”
Biotronik will continue to drive innovative, minimally invasive solutions for physicians treating lower limb arterial disease. During 2011, further enhancements to the percutaneous transluminal angioplasty 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 optimised 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.