Medinol announced that it obtained CE-mark for EluNIR™, its novel Drug Eluting Stent. This stent features a unique design to optimize clinical outcomes. The EluNIR will feature a low metal footprint and a proprietary elastomeric coating. EluNIR has demonstrated impressive outcomes in two randomized pivotal studies.
Medinol’s Chief Scientific Officer, Dr. Yoram Richter, stated “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.”
Dr. Alaide Chieffo noted, “Our first cases were very successful and the EluNIR stent system with its metallic spring tip demonstrated high deliverability. 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 patient’s’ progress.”
EluNIR will be available to select centers in Europe and other locations by late 2017. In 2018, a full range of sizes will be available. The EluNIR Stent System is an investigational device, not available for sale in the United States and Japan.