Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries.
The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in the U.S., according to the companies.
In a global pivotal trial of 1,919-patients, the Elunir drug-eluting stent had a 5.4% target lesion failure rate and no late stent thrombosis after one year.
“The Bionics study demonstrated the excellent performance of the Elunir DES in a broad, less selected, ‘more comers’ population,” principal investigator Dr. David Kandzari said in prepared remarks. “Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery disease.”
Medinol won CE Mark clearance for the stent in late-October and then revealed that it inked a long-term distribution agreement with Cordis for its coronary stent portfolio in the U.S.
“The FDA approval of the Elunir stent expands the Cordis portfolio with a DES designed for deliverability, in even highly complex cases, with its novel stent and delivery system,” Luis Davila, Cordis’ VP of R&D, added. “Cordis is committed to ensuring physicians will soon have this new DES in their Cath Labs to deliver the best patient care available.”
“Medinol has a legacy of developing innovative interventional cardiovascular technologies, which has culminated today with the FDA approval of the Elunir DES,” Dr. Yoram Richter, chief scientific officer at Medinol, said.
“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 U.S.”
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