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Medtronic (NYSE:MDT) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved its heart valve implant, the Evolut FX+ transcatheter aortic valve replacement (TAVR) system, for a cardiac disorder called aortic stenosis.
According to the company, Evolut FX+ , the latest in its Evolut TAVR portfolio, will continue to offer the valve performance of previous iterations with access to coronary arteries of varying sizes.
With a modified diamond-shaped frame design, the Evolut FX+ TAVR is designed to access coronary arteries four times larger than previous versions could reach.
According to the FDA labeling, Evolut FX will be indicated for symptomatic severe aortic stenosis, irrespective of the risk category.
"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 Jeffrey Popma, chief medical officer of MDT's coronary & renal denervation business.
The company expects to launch the product in the summer of 2024 after an early rollout in the spring.
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