Medtronic fully launches its next-generation TAVR in the United States

The Evolut FX TAVR [Image courtesy of Medtronic]

Medtronic (NYSE: MDT) kicked off TCT 2022 today by announcing the full U.S. launch of its Evolut FX TAVR system.

The medical technology giant’s next-generation TAVR won FDA approval in 2021, followed by a limited rollout earlier this year. Edwards Lifesciences – Medtronic’s leading US competitor in transcatheter aortic valve replacement – ​​announced the launch of its next-generation Sapien 3 Ultra Resilia heart valve earlier this week.

The Evolut FX system incorporates design changes. For example, it includes gold markers integrated into the frame to provide implanters with direct visualization of commissure alignment.

There is also a redesigned catheter tip for a smoother insertion profile. Delivery system flexibility features include an optimized stability layer for a more stable and predictable deployment. As with its predecessor Evolut Pro+, there are four valve sizes – a wide indicated patient treatment range. Medtronic claims that the Evolut FX has the lowest delivery profile currently on the market.

“This represents an important milestone for our structural heart business, as we seek to set new expectations for TAVR delivery systems and optimize patient outcomes. These innovations will provide physicians with better predictability of implants, improving the overall reliability of the procedure,” said Dr. Jeffrey Popma, vice president and medical director of the Structural Heart & Aortic business, which is part of the portfolio. Cardiovascular from Medtronic.

Medtronic at TCT will also unveil the results of four studies it says will highlight some of the latest clinical insights into TAVR.

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