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FDA Calls For More Review Of Aortic Valve Reduced Leaflet Motion

The agency issued a notification that recent advanced imaging studies have shown reduced leaflet motion in bioprosthetic aortic valves. While FDA believes the devices are reasonably safe and effective, it is working with cardiology societies to design new clinical studies to explore the phenomenon.

Newly published advanced imaging studies have detected reduced leaflet motion in some bioprosthetic aortic valves, but the valves are still safe and effective, FDA says in an Oct. 5 notification

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• By Natasha Barrow

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

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