FDA Approves EluNIR Drug-Eluting Stent
The device, which has the narrowest strut width of any stent on the market, was approved on the basis of the nearly 2,000-patient BIONICS study.
The US Food and Drug Administration has approved the EluNIR ridaforolimus-eluting stent for the treatment of patients with coronary artery disease, according to an announcement today from device makers Cardinal Health and Medinol.
EluNIR, a cobalt-chromium stent with very narrow struts, was approved based on results from the BIONICS study, which was presented by David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA), at TCT 2016 in Washington, DC.
In BIONICS, the EluNIR stent had a rate of target lesion failure at 12 months similar to that seen with the Resolute zotarolimus-eluting stent (Medtronic) in a broad population of patients with complex coronary artery disease. The rate of stent thrombosis was low in the trial–0.4% with the EluNIR device–and there were no reported cases of very late stent thrombosis.
The new stent, which has the narrowest strut width of currently marketed stents, is made up of a combination of flexible 40-µm struts with 72-µm supportive struts for radial strength. It has a permanent elastomeric polymer and a metallic radiopaque spring tip to enhance deliverability and visibility.
EluNIR is the first drug-eluting stent outside of those manufactured by Boston Scientific, Medtronic, and Abbott Vascular to gain a US foothold. Cardinal Health, which acquired Cordis in 2015, will market EluNIR in the United States.
The EluNIR stent gained CE Mark approval in Europe in August 2017.