Abbott Ends US Sale, Distribution of Trifecta Aortic Valves
The action follows an FDA letter to professionals in February warning of a potential for structural failure.
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The action follows an FDA letter to professionals in February warning of a potential for structural failure.
The Food and Drug Administration has issued a safety alert regarding the potential risk of early structural valve deterioration with Abbott Trifecta valves.
Some evidence suggests early structural valve deterioration is more common with these valves than others on the market.
Abbott and the FDA are telling health providers that the company's Trifecta family of heart valves could deteriorate early.
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA is withdrawing...