December 13, 2017 — Cordis, a Cardinal Health company, and Medinol recently announced U.S. Food and Drug Administration (FDA) 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 is designed with a novel metallic spring tip and the narrowest strut width of any stent on the U.S. market, according to the companies, to help clinicians easily deliver this new DES in highly complex anatomy and disease.
The EluNIR DES demonstrated outstanding efficacy and safety results in two randomized clinical trials, including BIONICS, a global pivotal study of 1,919 patients from 76 sites in eight countries. In BIONICS, the EluNIR stent demonstrated a 5.4 percent target lesion failure (TLF) and a 0 percent rate of late stent thrombosis at 12 months. Medinol recently obtained CE-mark for the EluNIR stent, and it is currently being used by physicians in Europe.
"The BIONICS study demonstrated the excellent performance of the EluNIR DES in a broad, less selected, ‘more comers’ population," said David Kandzari, M.D., FACC, director of interventional cardiology at Piedmont Heart Institute in Atlanta, and principal investigator for the BIONICS trial. “Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery 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 NIRxcell, a cobalt-chromium bare metal stent (BMS), in the U.S.
For more information: www.cordis.com, www.medinol.com