FDA approves DES system for narrowing, blocked coronary arteries

Cordis and Medinol have announced the FDA approval of a drug-eluting stent system for the treatment of patients with narrowing or blockages in coronary arteries.

According to a press release, the EluNIR stent system is designed with a novel metallic spring tip and has the narrowest strut width of any stent currently available in the U.S. market, assisting physicians to more effectively deliver the DES in this patient group.

The FDA approval came following the results of the BIONICS trial, which showed that the DES system was safe and effective and demonstrated a 5.4% target lesion failure, as well as no occurrences of late stent thrombosis at 12 months.

The release states that the DES system was recently given a CE mark and is currently available for use by physicians in Europe and has been added to Medinol’s stent portfolio.

"The BIONICS study demonstrated the excellent performance of the EluNIR DES in a broad, less selected, 'more comers' population," David Kandzari, MD, FACC, director of interventional cardiology at Piedmont Heart Institute in Atlanta and principal investigator for the BIONICS trial, said in the release. "Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery disease."

Disclosure: Kandzari reports that he receives consultant fees from Boston Scientific, Medtronic, Micell and St. Jude Medical, as well as research support from Abbott Vascular, Biotronik, Boston Scientific, Medinol, Medtronic and St. Jude Medical.

Cordis and Medinol have announced the FDA approval of a drug-eluting stent system for the treatment of patients with narrowing or blockages in coronary arteries.

According to a press release, the EluNIR stent system is designed with a novel metallic spring tip and has the narrowest strut width of any stent currently available in the U.S. market, assisting physicians to more effectively deliver the DES in this patient group.

The FDA approval came following the results of the BIONICS trial, which showed that the DES system was safe and effective and demonstrated a 5.4% target lesion failure, as well as no occurrences of late stent thrombosis at 12 months.

The release states that the DES system was recently given a CE mark and is currently available for use by physicians in Europe and has been added to Medinol’s stent portfolio.

"The BIONICS study demonstrated the excellent performance of the EluNIR DES in a broad, less selected, 'more comers' population," David Kandzari, MD, FACC, director of interventional cardiology at Piedmont Heart Institute in Atlanta and principal investigator for the BIONICS trial, said in the release. "Clinicians now have another safe, reliable option for treating the many patients whose lives are impacted by coronary artery disease."

Disclosure: Kandzari reports that he receives consultant fees from Boston Scientific, Medtronic, Micell and St. Jude Medical, as well as research support from Abbott Vascular, Biotronik, Boston Scientific, Medinol, Medtronic and St. Jude Medical.