Medtronic plc., a healthcare technology company, has received approval from the United States Food and Drug Administration (FDA) for its Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis.

The Evolut FX+ TAVR system, the latest addition to Medtronic's innovative TAVR platform, maintains the superior valve performance of its predecessor while introducing enhancements designed to facilitate coronary access. With a modified diamond-shaped frame design, the Evolut FX+ offers larger coronary access windows, providing increased space for catheter maneuverability to reach coronary arteries of varying patient anatomies.

Dr. Jeffrey Popma, Vice President and Chief Medical Officer for Medtronic's Cardiovascular Portfolio, expressed the company's commitment to advancing minimally invasive solutions for physicians treating patients with aortic stenosis. "We are committed to consistently developing and advancing minimally invasive solutions for physicians to treat their patients with aortic stenosis. This is reinforced by our continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years. The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance," said Popma. 

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened, hindering proper opening and closing. This condition forces the heart to work harder to pump blood throughout the body, significantly impacting patients' quality of life and daily activities. If left untreated, it can lead to heart failure, with a mortality rate of up to 50 percent within two years for symptomatic severe aortic stenosis patients.

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories, including extreme, high, intermediate, and low risk. The system is set to undergo early commercial experience in spring 2024, with a full product launch expected in summer 2024.