FDA Approval Expands Indication for Medtronic's Resolute DES to Treat De Novo CTO
February 26, 2019—Medtronic announced FDA approval of an expanded indication for its Resolute drug-eluting stent (DES) platform for the treatment of patients with coronary artery disease who have de novo chronic total occlusions (CTOs). The platform includes the Resolute Onyx DES and the Resolute Integrity DES.
According to Medtronic, the expanded CTO indication was supported by data from the single-center, observational PERSPECTIVE study of 183 patients with CTOs who underwent stent placement with the older-generation Resolute Integrity DES. In the study, patients with CTOs treated with the Resolute DES exhibited low rates of repeat revascularization (1.1%), cardiac death (2.2%), and minimal stent thrombosis (0.6%) at 1 year.
The newer-generation Resolute Onyx DES, which was approved in the United States in 2017, features the company's core wire technology and is available in a size matrix covering 2.0 to 5.0 mm. It can be used in complex CTO lesions in a broad range of vessel sizes, advised Medtronic.
David Kandzari, MD, is Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia, and Principal Investigator in the PERSPECTIVE study.
In Medtronic's announcement, Dr. Kandzari commented, "Revascularization of CTO presents physicians with many challenges—both regarding procedural technique and tools—given the patient and disease complexity. In part because of these challenges, CTO remains undertreated in interventional cardiology. The newest-generation, thin-strut Resolute Onyx DES, in particular, is well-suited to address the procedural challenges of deliverability and conformability, with now-demonstrated excellent early and late safety and efficacy."