Israel-based Medinol has secured CE mark approval for its EluNIR ridaforolimus-eluting coronary stent system.
EluNIR features an advanced stent design, which combines narrow and ultra-narrow struts that enhance conformability and scaffolding while maintaining radial strength and low metal footprint.
The stent is coated with an elastomeric polymer that provides a uniform surface, helping to prevent the pro-inflammatory cracking or peeling that may happen with brittle polymers.
Medinol produces and coats the stent in flat panels by using its patented QualitySurface technology. EluNIR is coated with ridaforolimus, which is a limus family drug that will prevent restenosis.
EluNIR S is an investigational device in the US, and will not commercially available in the country.
Medinol has tested the new drug eluting stent in two randomized pivotal studies, including Bionics and Nireus, which showed better results.
The company will initially distribute the EluNIR stent in select centers in Europe and other geographies by late 2017,
Medinol will offer the stent in full range of sizes, including 38mm and 44mm lengths, in early 2018.
Medinol chief scientific officer Dr Yoram Richter said: “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.”
Image: Medinol’s EluNIR drug eluting stent. Photo: courtesy of Medinol Ltd.