Abbott is ending sale and distribution of its Trifecta prosthetic valves in the United States "and will be removing the limited remaining inventory from the field," the company announced Monday.
The family of devices includes the Trifecta Valve, approved in 2011, and the Trifecta Valve with Glide Technology (Trifecta GT), on the US market since 2016.
The move follows the February 2023 letter to healthcare professionals from the US Food and Drug Administration (FDA) warning that the valves have potential for structural failure, offering guidance on discussing the risk to patients, and recommending close clinical and echocardiographic follow-up of those already with the devices.
Monday, the FDA updated its February cautionary message with information on the product withdrawal and reiteration of its earlier recommendations.
Trifecta valves, designed for surgical aortic valve replacement, feature a titanium stent frame covered in bovine pericardial tissue. In its February statement, the FDA said it had received Medical Device Reports describing early structural valve deterioration, usually 3-4 years after implantation, leading to explantation, surgical or transcatheter replacement, "and in some cases death."
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Cite this: Abbott Ends Sale, Distribution of All Trifecta Aortic Valves in US - Medscape - Aug 01, 2023.