FDA expands approval of Resolute DES platforms in coronary artery disease.- Medtronic

Medtronic announced the FDA approval of its Resolute Drug-Eluting Stent (DES) platform (including the Resolute Onyx and Resolute Integrity(DES) for the treatment of patients with coronary artery disease who have de novo chronic total occlusion (CTO), a complex vessel condition involving complete blockage of a coronary artery. CTO is considered more difficult to treat with percutaneous coronary intervention (PCI) due to a greater risk of complications.

The expanded CTO indication was supported by data from the PERSPECTIVE Study, a single-center, observational study of 183 CTO patients who underwent a stent procedure with the older-generation Resolute Integrity(TM) DES. Results showed that patients treated with the Resolute DES exhibited low rates of repeat revascularization (1.1 percent), cardiac death (2.2 percent) and minimal stent thrombosis (0.6 percent) at one year.

Comment: Approved in the U.S. in 2017 following Resolute Integrity DES, the newest-generation Resolute Onyx is the first and only DES to feature Core Wire Technology, a unique Medtronic method of stent manufacturing that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. Core Wire Technology enables greater deliverability and conformability to the vessel wall, along with thinner struts while maintaining structural strength. With a size matrix covering 2.0-5.0 mm, physicians can use Resolute Onyx in complex CTO lesions in a broad range of vessel sizes.