BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced the results from two independent clinical studies concerning their Pulsar-18 self-expanding stent system at the CIRSE (Cardiovascular and Interventional Radiological Society of Europe) 2013 congress in Barcelona, Spain. 24-month results from the prospective, multi-center, 4EVER study were backed up by 12-month results from the multi-center, prospective PEACE registry, both of which shows Pulsar stent efficacy comparing very favorably with other bare metal stent study results.
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. 24-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 favorably 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 of 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 TLR at the rate of 81%, with no significant difference between popliteal vs. non-popliteal and diabetics vs. non-diabetics.
Dr. Marc Bosiers, Chief of Surgery at AZ Sint-Blasius in Dendermonde, Belgium presented the results of the 4EVER study in a dedicated BIOTRONIK satellite symposium at CIRSE 2013. He was joined by Prof. Dr. Günther Wittenberg, Chief of the Institute for Diagnostic and Interventional Radiology at the Evangelisches Krankenhaus (Protestant Hospital) Bielefeld, Germany, who presented the latest results of the PEACE registry.
"The results of these two studies have clearly demonstrated the efficacy of treating symptomatic SFA disease," commented Dr. Wittenberg. "Both 4EVER at 24 months and PEACE at 12 months confirm that the Pulsar stent with optimal radial force combined with high flexibility is favorable to stents that concentrate mainly on high radial force in treating SFA disease," added Dr. Bosiers.
"The new 12-month data from the PEACE registry closely mirror the 4EVER results we received, a credit to the Pulsar stent's state-of-the-art design," commented Dr. Alexander Uhl, Vice President Marketing, Vascular Intervention at BIOTRONIK. "Pulsar stents feature an innovative, highly flexible design and a PROBIO coating, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility. We have invested heavily in clinical studies aimed at providing data to further support Pulsar stents in a variety of clinical settings, and we are very pleased that Pulsar-18 has shown such favorable results in comparison to other stents on the market."