Coronary stent system receives CE mark

31st October 2017

Medinol

Enaie Azambuja

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Medinol has 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 optimise clinical outcomes. EluNIR demonstrated outstanding outcomes in two randomised 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 optimising 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.