Medinol's EluNIR DES Receives CE Mark Approval
October 26, 2017—Medinol USA announced that it has obtained European CE Mark approval for its EluNIR ridaforolimus-eluting coronary stent system, which features a low metal footprint and the company's elastomeric coating. Medinol also announced that the first European postapproval patient implantations of EluNIR were performed at San Raffaele Hospital in Milan, Italy.
EluNIR will be available to select centers in Europe and other locations by late 2017. A full range of sizes, including 38- and 44-mm lengths, will be available in early 2018. The EluNIR stent system is an investigational device and is not available for sale in the United States or Japan, advised the company.
According to Medinol, EluNIR was evaluated in two randomized pivotal studies, BIONICS and NIREUS.
In BIONICS, a more-comers study conducted in the United States, Canada, Europe, and Israel, EluNIR showed a 12-month target lesion failure rate of 5.4% and a 0% rate of late stent thrombosis (n = 958), demonstrating noninferiority to the Resolute zotarolimus-eluting stent (Medtronic).
In NIREUS, a study conducted in Europe and in Israel, EluNIR demonstrated in-stent late loss of 0.04 mm at 6 months (n = 201).
Alaide Chieffo, MD, who conducted the first postapproval procedures, commented in the company's announcement, "Our first cases were very successful and the EluNIR stent system with its metallic spring tip demonstrated high deliverability. The first case involved left anterior descending artery disease distal to a very tortuous left internal mammary artery. The second case involved a severely calcified and diseased left anterior descending artery that could not be crossed with another new-generation DES despite lesion preparation with Rotablator (Boston Scientific Corporation), and was successfully treated with EluNIR. In a third case, the lesion was in a proximal right coronary artery 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."