Update: On July 31, Abbott announced that they will stop selling and distributing Trifecta valves in the U.S. and has informed customers to return unused Trifecta valves. The U.S. Food and Drug Administration (FDA) continues to work with the manufacturer to further evaluate the potential risk of early structural valve deterioration in patients implanted with Trifecta valves.

The FDA had released a letter on Feb. 27 warning health care providers about the potential risk of early structural valve deterioration with Abbott Trifecta valves, including the Trifecta valve and Trifecta valve with Glide Technology.

The agency cited published literature that "suggests a higher cumulative incidence of early (five years or less) [structural valve deterioration] for Trifecta valve compared to other commercially available surgical bioprosthetic valves," and encouraged health care providers to report any adverse events involving Trifecta valves to the FDA.

For more information and recommendations, access the agency's full letter.

Clinical Topics: Cardiac Surgery

Keywords: Heart Valve Prosthesis, Bioprosthesis, United States, Incidence, United States Food and Drug Administration, ACC Advocacy

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