Cordis and Medinol Announce FDA Approval of the EluNIR DES
November 30, 2017—Cordis, a Cardinal Health company, and Medinol USA announced US Food and Drug Administration approval of the EluNIR drug-eluting stent (DES) for the treatment of patients with narrowing or blockages to their coronary arteries. The EluNIR stent system features a metallic spring tip and narrow strut width to help clinicians deliver the device in highly complex anatomy and disease.
Cardinal Health's long-term distribution agreement with Medinol enables Cordis, Cardinal Health's interventional vascular business, to sell Medinol's coronary stent portfolio, which now includes the EluNIR DES and the NIRxcell cobalt-chromium bare-metal stent in the United States.
According to the companies, the EluNIR DES demonstrated its safety and efficacy in randomized clinical trials, including BIONICS, a global pivotal study of 1,919 patients at 76 sites in eight countries. In BIONICS, the EluNIR stent demonstrated a 5.4% rate of target lesion failure and a 0% rate of late stent thrombosis at 12 months. In October, Medinol announced European CE Mark approval for the EluNIR stent.
In the companies' announcement, BIONICS Principal Investigator David Kandzari, MD, commented, "The BIONICS study demonstrated the excellent performance of the EluNIR DES in a broad, less-selected, 'more comers' population. Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery disease."