Medtronic has received US FDA approval of its Resolute drug-eluting stent platform—including the Resolute Onyx and Resolute Integrity—for the treatment of patients with coronary artery disease who have de novo chronic total occlusion. Chronic total occlusions are considered to be more difficult to treat with percutaneous coronary intervention (PCI) than non-chronic total occlusions because of a greater risk of complications.
According to a press release, the expanded indication was supported by data from the PERSPECTIVE Study, a single-centre, observational study of 183 patients with chronic total occlusions who underwent a stent procedure with the older-generation Resolute Integrity. Results showed that patients treated with the Resolute device exhibited low rates of repeat revascularisation (1.1%) cardiac death (2.2%) and minimal stent thrombosis (0.6%) at one year.
David Kandzari (Piedmont Heart Institute, Atlanta, USA), principal investigator in the PERSPECTIVE study, comments: “Revascularisation of chronic total occlusions presents physicians with many challenges—both regarding procedural technique and tools—given the patient and disease complexity. In part because of these challenges, chronic total occlusion remains undertreated in interventional cardiology. The newest-generation, thin-strut Resolute Onyx, in particular, is well-suited to address the procedural challenges of deliverability and conformability, with now demonstrated excellent early and late safety and efficacy.”
Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic, states: “This expanded indication will allow physicians the option to treat these more complex chronic total occlusion cases with the Resolute Onyx, which has shown strong clinical performance across a variety of vessel sizes and anatomies. Medtronic is committed to helping interventional cardiologists better treat the tough, complex coronary cases that have historically required more invasive treatment options, such coronary artery bypass grafting.”