Cordis and Medinol have announced that the US FDA has approval the Elunir drug-eluting stent for the treatment of patients with coronary artery disease. The stent, a press release reports, is designed with a novel metallic spring tip; it has the narrowest strut width of any stent on the US market.
According to the press release, the Elunir drug-eluting stent demonstrated outstanding efficacy and safety results in two randomised clinical trials, including BIONICS (a global pivotal study of 1,919 patients from 76 sites in eight countries).
In BIONICS, the stent was associated with a 5.4% rate of target lesion failure—the lowest reported target lesion failure rate in a contemporary US pivotal study—and a 0% rate of late stent thrombosis at 12 months. Medinol recently obtained CE-mark for the Elunir stent, and the stent is currently being used by physicians in Europe.
David Kandzari (Piedmont Heart Institute, Atlanta, USA), principal investigator for the BIONICS trial, comments: “The BIONICS study demonstrated the excellent performance of the Elunir drug-eluting stent 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.”
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 drug-eluting stent and Nirxcell, a cobalt-chromium bare metal stent in the USA.
“The FDA approval of the Elunir stent expands the Cordis portfolio with a drug-eluting stent designed for deliverability, in even highly complex cases, with its novel stent and delivery system. Cordis is committed to ensuring physicians will soon have this new drug-eluting stent in their Cath Labs to deliver the best patient care available,” says Luis Davila, vice president of R&D at Cordis.