Medinol Ltd. Receives CE Mark for the EluNIR™ Ridaforolimus-Eluting Coronary Stent System, and announces first commercial implantations
October 26, 2017
Medinol, a global Interventional Cardiology device company, announced that it obtained CE-mark for EluNIR™, its novel Drug Eluting Stent featuring a unique stent design with low metal footprint and a proprietary elastomeric coating, both designed to optimize clinical outcomes. EluNIR demonstrated outstanding outcomes in two randomized pivotal studies. In BIONICS, a more-comers study conducted in the United States, Canada, Europe and Israel, EluNIR showed outstanding results including a 12 month TLF rate of 5.4% and 0% Late Stent Thrombosis (n=958), and was non-inferior to the Resolute Zotarolimus eluting stent. In NIREUS, a study conducted in Europe and in Israel, EluNIR demonstrated unprecedented results with an in-stent Late Loss of 0.04mm at 6 months (n=201).
“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” said Dr. Yoram Richter, Chief Scientific Officer of Medinol.
Medinol also announced the first post CE-mark patient implantations of EluNIR. The first procedures were performed at San Raffaele Hospital in Milan, Italy. “Our first cases were very successful and the EluNIR stent system with its metallic spring tip demonstrated high deliverability” said Dr. Alaide Chieffo. “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” said Dr. Chieffo.
EluNIR will be available to select centers in Europe and other geographies by late 2017. A full range of sizes, including 38mm and 44mm lengths, will be available in early 2018.
The EluNIR Stent System is an investigational device, not available for sale in the United States and Japan.
About the EluNIR Stent System
EluNIR features a unique stent design combining narrow and ultra-narrow struts intended to enhance conformability and scaffolding while maintaining radial strength and a very low metal footprint. EluNIR is coated with a proprietary elastomeric polymer that maintains a smooth and uniform surface designed to prevent the pro-inflammatory cracking or peeling that may occur with brittle polymers. Medinol manufactures and coats the stent in flat panels utilizing its patented QualitySurface™ technology, ensuring quality, consistency and control over the coating and elution characteristics. EluNIR is coated with ridaforolimus, a “limus” family drug which is intended to prevent restenosis. The delivery system is unique, featuring a distinctive spring tip that is simultaneously more pushable and flexible than the conventional plastic tips used on other delivery systems.
Medinol Ltd., headquartered in Israel, with US offices in Parsippany, NJ is dedicated to the science of cardiovascular intervention. For over 20 years, its in-house research, development, and manufacturing have continuously raised the bar for quality and performance of stenting systems. In 2014 Medinol established its first sales office in the US and launched its first product sold directly to hospitals, the NIRxcell™ bare metal stent. With over two million stents deployed to date, Medinol’s cutting-edge cardiovascular intervention technology continues to demonstrate extraordinary clinical results, and its products constantly stretch the limits of innovation.