News | Stents Drug Eluting | February 02, 2016

Medtronic Announces New Sizes, Indications for Resolute Onyx Drug-eluting Stent

New extra-large vessel stent sizes and indications in the EU expand treatment options for patients with coronary artery disease

Medtronic, CE Mark, Resolute Onyx DES, drug-eluting stent, expanded sizes and indications

February 2, 2016 — Medtronic plc announced the recent CE Mark and commercial launch for an expanded size matrix of the Resolute Onyx DES, a next-generation drug-eluting stent now available in 4.5 and 5 mm diameter sizes. The CE Mark also approved several new product indications including treatment of left main vessels and small vessels.

Many coronary vessels are large in diameter, of which a subset are left main, and now physicians can treat these large vessels with optimally sized stents that provide appropriate drug concentration. Resolute Onyx is the first DES available in these sizes among major manufacturers, offering the broadest size matrix to optimize the treatment of complex clinical scenarios. The device is not commercially available in the United States.

Treatment of the left main coronary artery is critical, as the artery supplies the majority of blood to the left side of the heart; a narrowing in this vessel can place the patient at high risk for life-threatening events. Due to the lack of optimally sized drug-eluting stents available to date to treat large coronary arteries, these patients historically have been treated with undersized stents or with coronary artery bypass graft surgery (CABG). CABG can be more invasive and may require a longer recovery period than treatment with drug-eluting stents, while under-sized stents may have compromised stent scaffold integrity and disrupted polymer coating when over-expanded.

Resolute Onyx DES is well-suited to treat large coronary vessels, including the left main coronary artery, with its optimal sizes and conformability in bifurcation lesions due to Continuous Sinusoid Technology.

“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,” said David Hildick-Smith, M.D., principal investigator of the EBC Main Study who performed the first patient case with the larger sized Resolute Onyx from the Brighton and Sussex University Hospitals NHS Trust in Brighton, United Kingdom. “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.”

Built on the clinical performance and deliverability of the Resolute Integrity DES, the expanded sizes feature the same CoreWire Technology that allows the stent to have a denser core metal wrapped in a cobalt alloy outer layer. This technology enables increased radiopacity (i.e., visibility during the procedure) and has thinner struts to help improve deliverability without compromising radial and longitudinal strength. The full size matrix of Resolute Onyx features a delivery system with PowerTrac technology that provides enhanced deliverability through challenging lesions.

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