Irish medical technology firm Medtronic has secured expanded approval from the US Food and Drug Administration (FDA) for its Resolute Drug-Eluting Stent (DES) platform to treat patients with coronary artery disease (CTO).
Image: The FDA has granted expanded approval for Medtronic’s Resolute drug-eluting stent platform. Photo: courtesy of Medtronic.
The Resolute DES platform, including Resolute Onyx and Resolute Integrity DES, has received expanded indication to treat coronary artery disease who have de novo CTO, which is a complex vessel condition that involves in complete blockage of coronary artery.
CTO takes place when there is heavy build-up of atherosclerotic plaque within the artery, and is affects between 20% and 30% of patients undergoing routine diagnostic coronary angiography.
The expanded CTO indication was approved based on data from the Perspective syudy, which is a single-center and observational study of183 CTO patients who underwent a stent procedure with the older-generation Resolute Integrity(TM) DES.
Results demonstrated that patients treated with the Resolute DES exhibited low rates of repeat revascularization with 1.1%, cardiac death with 2.2% and minimal stent thrombosis with 0.6% at one year.
The newest-generation Resolute Onyx, which was approved in the US in 2017 following Resolute Integrity DES, is claimed to be the first and only DES to feature Core Wire technology.
Core Wire technology is the firm’s advanced method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to build a stent.
The technology allows better deliverability and conformability to the vessel wall, along with thinner struts while maintaining structural strength.
Physicians can use Resolute Onyx in complex CTO lesions in a wide range of vessel sizes, with a size matrix ranging from 2.0mm to 5.0mm.
Medtronic coronary and renal denervation business general manager and vice president Dave Moeller said: “This expanded indication will allow physicians the option to treat these more complex CTO cases with the Resolute Onyx DES, 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 (CABG), or open-heart surgery.”