Medinol said today that it won CE Mark clearance for its EluNir drug-eluting stent – a device designed with a low metal footprint and an elastomeric coating.
In one 958-patient clinical study, the coronary stent had a 12-month target lesion failure rate of 5.4% and a 0% rate of late stent thrombosis, proving non-inferior to the Resolute zotarolimus-eluting stent.
“EluNir is the culmination of over 20 years of Medinol research, development and science dedicated to improving clinical outcomes with coronary stent systems. Given the excellent results we have observed in our clinical studies for EluNir, and the renewed focus on metallic drug-eluting stents, we are excited to bring EluNir to the European interventional cardiology community as physicians continue to drive towards optimizing results for their patients,” chief scientific officer Yoram Richter said in prepared remarks.
The company also announced today the first patient implantations of the EluNir device, performed at the San Raffaele Hospital in Italy.
“Our first cases were very successful and the EluNir stent system with its metallic spring tip demonstrated high deliverability” Dr. Alaide Chieffo said.
“The first case involved LAD disease distal to a very tortuous LIMA. The second case involved a severely calcified and diseased LAD that could not be crossed with another new generation DES despite lesion preparation with Rotablator, and was successfully treated with EluNir. In a third case, the lesion was in a proximal RCA with unfavorable take-off and insufficient guiding-catheter support, and was also treated nicely with EluNir. I have confidence in the longer term outcome as we continue to follow the patients’ progress.”
Medinol said its coronary stent will be available for select centers in Europe later this year and that a full range of sizes will be available early next year.