Medtronic wins expanded CE Mark for larger Resolute Onyx stent

Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a expanded indications and sizes for its Resolute Onyx drug-eluting stent.

The Resolute Onyx device is based on Medtronic’s Resolute Integrity DES, but uses the Fridley, Minn.-based firm’s new CoreWire technology to wrap a cobalt alloy around a denser metal to increase radiopacity and allow for thinner struts, according to a press release.

The device was cleared for 4.5mm and 5.0mm diameter sizes of the device, and new indications include treatment of left main vessels and small vessels, and the devices will be available commercially moving forward.

“My initial clinical experience with the large sizes of the Resolute Onyx DES has been exceptional, as they 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,” EBC left main principal investigator Dr. David Hildick-Smith said in a press release.

The newly available sizes and clearances allow for better treatment of the left main coronary artery, Medtronic said, as it has “optimal sizes and conformability,” according to the press release.

“The expanded size matrix of Resolute Onyx, and the new indication to treat the left main vessel, further delivers on our promise to provide the interventional community with stent innovations that address unmet clinical needs seen in everyday clinical practice. We now have a stent that treats a broader range of patient anatomies – from large to small – than any other major DES on the EU market,” coronary and renal denervation GM Jason Weidman said in prepared remarks.

The Resolute Onyx stent is currently not available in the U.S., though last March the company launched a pivotal U.S. trial for the Resolute Onyx drug-eluting stent, with the 1st phase of the study slated to include patients with small vessels requiring a 2.0mm stent, while core sizes of the Resolute Onyx stent will be studied separately.

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