Biotronik presents results of 4EVER study of Pulsar stent

Biotronik presented at CIRSE (Cardiovascular and Interventional Radiological Society of Europe) 2013 congress in Barcelona, Spain the 24-month results from the prospective, multi-center, 4EVER study , backed up by 12-month results from the multi-center, prospective PEACE registry, both of which shows Pulsar stent efficacy.

The 4EVER study investigated both the acute and long-term performance of 4 F-compatible devices in superficial femoral artery (SFA) lesions. The study examined the efficacy of Pulsar stents and the feasibility of treating patients with 4 F devices from Biotronik, including the Fortress 4 F sheath, Astron Pulsar and Pulsar-18 stents. Twenty-Four month data from the 4EVER study for the full cohort of 120 patients showed an impressive 72.3% primary patency rate and a freedom from Target Lesion Revascularization (TLR) rate of 82.7% with no significant difference between calcified and non-calcified lesions. These results compared very favourably with reported data from other bare metal stent studies (DURABILITY II, SUPERA, STROLL) at the same time point and in similar lesion lengths and patient demographics.

Results from the PEACE registry at 12 months were taken from the enrolled 200 patients, with 118 patients receiving follow-up after 12 months. The primary patency rate was 79.5%, with a freedom from Target Lesion Revascularization at the rate of 81%, with no significant difference between popliteal vs. non-popliteal and diabetics vs. non-diabetics.