FDA approved the EluNIR drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. Isreal-based Medinol developed the new DES, and Dublin, Ohio-based Cordis has exclusive distribution rights for the U.S. market.
The EluNIR DES is one way Cordis, now a Cardinal Health company, is trying to make a come back in the stent business. The device, which was recently cleared for sale in Europe, has shown a lot of promise in two randomized trials including more than 2,200 patients in the United States, Canada, Europe, and Israel. FDA approval was supported by data from the BIONICS study, which included 1,919 patients from 76 sites in eight countries. In that study, the device demonstrated a 5.4% target lesion failure (TLF), the lowest reported TLF in a contemporary U.S. pivotal study, and a 0% rate of late stent thrombosis at 12 months.
The stent is designed with a metallic spring tip and the narrowest strut width of any stent on the U.S. market to help clinicians easily deliver the device in highly complex anatomy and disease.
“Medinol has a legacy of developing innovative interventional cardiovascular technologies, which has culminated today with the FDA approval of the EluNIR DES,” said Yoram Richter, MD, chief scientific officer at Medinol. “For more than 20 years, Medinol has continuously raised the bar for the quality and performance of stenting systems. With our innovative manufacturing process, the EluNIR DES offers clinicians the latest generation DES. Notably, the FDA approval of the EluNIR DES marks the first such approval for a privately held company based outside of the [United States]."