Medtronic has announced the recent CE mark receipt and commercial launch for an expanded size matrix of the Resolute Onyx drug-eluting stent (DES), a next generation DES that is now available in 4.5mm and 5mm diameter sizes. The CE mark also approved several new product indications including treatment of left main vessels and small vessels.
According to Medtronic, Resolute Onyx is the first DES available in these sizes among major manufacturers, offering the broadest size matrix to optimise the treatment of complex clinical scenarios. The Resolute Onyx DES is not commercially available in the United States.
Accroding 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 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,” says David Hildick-Smith, 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, designed to allow 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 which should provide enhanced deliverability through challenging lesions.
“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,” says Jason Weidman, vice president and general manager of the coronary and renal denervation business unit at Medtronic. “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.”