Biotronik Pulsar SFA Stent Study Suggests It’s Just As Good With Heavily Calcified Lesions

In short

Twice in one week! That’s a lot of press release even for Biotronik, the German based developer of ICD and monitoring solutions. Now the company has announced the twelve-month results from the prospective, multicentre, single-arm 4EVER study, which it says demonstrates the efficacy and safety of its Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.

Background

Pulsar stents feature an innovative, highly flexible design coated with PROBIO, a silicon carbide layer that improves the stent’s hemocompatibility and biocompatibility—which Biotronik believes may have contributed to the stent’s excellent clinical results.

Twelve-month data for the full cohort showed 81.4% primary patency rate and a freedom from TLR (target lesion revascularisation) 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%.

Dr. 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.

Investigator comments

“These results are certainly in line with published studies of similar lesion lengths using thick strut, high radial force stents,” said Dr. 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.”

Company comments

“The 4EVER results strongly suggest that Pulsar stent systems with optimal radial force combined with high flexibility are superior to systems which concentrate mainly on high radial force in treating SFA disease,” explained Alain Aimonetti, Vice President Sales and Business Development, Biotronik Vascular Intervention. “Our expectations are for an even greater differential in clinical outcomes when the 24-month data are presented. We have invested heavily in clinical studies aimed at providing data to further support Pulsar stents in a variety of clinical settings.”

Source: Biotronik AG