Cardinal Health’s interventional vascular business Cordis and stents maker Medinol have obtained approval from the US Food and Drug Administration (FDA) for the EluNIR drug-eluting stent (DES) to treat narrowing or blockages to coronary arteries.
Medinol’s EluNIR DES features a metallic spring tip and narrow strut width to allow easy and optimised delivery even in highly complex anatomy and disease.
In two randomised clinical trials, the DES system is reported to have shown favourable safety and efficacy profile.
During the BIONICS trial in 1,919 subjects at 76 sites across eight countries, the stent achieved 5.4% target lesion failure (TLF) and 0% late stent thrombosis rate at 12 months.
BIONICS trial principal investigator David Kandzari said: “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.”
Under a long-term distribution agreement between Cardinal Health and Medinol, Cordis can sell the Medinol’s coronary stent portfolio, including EluNIR and NIRxcell bare metal stent (BMS), in the US.
Cordis research and development (R&D) vice-president Luis Davila said: “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.
“Cordis is committed to ensuring physicians will soon have this new DES in their Cath Labs to deliver the best patient care available.”