Biotronik reported Tuesday that all 120 patients have been enrolled in the 4EVER clinical study evaluating the safety and efficacy of the Astron Pulsar and Pulsar-18 stents. 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," said Dr. Marc Bosiers, principal investigator of 4EVER. "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."
Biotronik announced the international full market release of Pulsar-18 stent for treatment of long lesions in the superficial femoral and infrapopliteal arteries last November. The stent is the next generation of the market-leading Astron Pulsar stent and provides physicians with longer lengths of 100 mm up to 200 mm, optimized radial force and improved flexibility in diameters from 4 mm to 7 mm.
"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."
- see the Biotronik release