New Sizes and Expanded Indications for Medtronic's Resolute Onyx DES Introduced in Europe

February 1, 2016—Medtronic plc announced the European CE Mark approval and the commercial launch of an expanded size matrix of the next-generation Resolute Onyx drug-eluting stent (DES) that is now available in 4.5- and 5-mm diameter sizes. The CE Mark approval also includes several new product indications, including treatment of left main vessels and small vessels.

According to Medtronic, 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 because of continuous sinusoid technology.

The Resolute Onyx DES expanded sizes feature the company’s CoreWire technology that allows the stent to have a denser core metal wrapped in a cobalt alloy outer layer. Additionally, this technology enables increased radiopacity 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.

The company noted that many coronary vessels are large in diameter, and this includes the left main coronary artery. With the approval, physicians can treat these large vessels with optimally sized stents that provide appropriate drug concentration. Resolute Onyx DES offers a broad size matrix to optimize the treatment of complex clinical scenarios. The Resolute Onyx DES is not commercially available in the United States.

David Hildick-Smith, MD, Principal Investigator of the European Bifurcation Club Left Main Study (EBCMain), performed the first patient case with the larger-sized Resolute Onyx DES at the Brighton and Sussex University Hospitals NHS Trust in Brighton, United Kingdom.

In Medtronic’s press release, Dr. Hildick-Smith commented, “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.”