Biotronik has announced the twelve-month results from the prospective, multicentre, single-arm 4EVER study, which demonstrates the efficacy and safety of the Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.
Twelve-month data for the full cohort showed 81.4% primary patency rate and a freedom from target lesion revascularisation (TLR) rate of 89.3%. The Pulsar-18 subgroup, which had an average lesion length of 10.5cm, showed a primary patency rate of 73.4% and freedom from TLR rate of 85.2%.
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 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 a highly flexible design coated with Probio, a silicon carbide layer that improves the stent’s haemocompatibility 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 20–200mm 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.