Medtronic’s drug-eluting stents get EU approval

Medtronic has been awarded CE (Conformité Européene) Mark for an expanded size matrix of the Resolute Onyx DES, a drug-eluting stent

The CE Mark also approved several new product indications including treatment of left main vessels and small vessels.

The left main coronary artery supplies the majority of blood to the left side of the heart.

Patients with a narrowing in this artery are often treated with coronary artery bypass graft surgery, which, according to Medtronic, can be more invasive and may require a longer recovery period than treatment with drug-eluting stents.

Resolute Onyx DES can treat large coronary vessels including the left main coronary artery with its newly CE marked sizes.

David Hildick-Smith, from the Brighton and Sussex University Hospitals NHS Trust in Brighton, United Kingdom performed the first patient case with the larger sized Resolute Onyx.

Hildick-Smith said: "The larger sizes of the Resolute Onyx DES alleviate many of the procedural challenges that existed when smaller stents were often the only option for large vessels.

"In addition, the left main indication of Resolute Onyx, coupled with its advanced stent design, provides physicians with a novel device that maintains its scaffold integrity with increased radial force, which is especially beneficial when treating bifurcation lesions in large vessels."

The Resolute Onyx DES is now available in 4.5mm and 5.0mm diameter sizes.