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."


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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.