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Aug 04, 2023

Abbott is pulling its Trifecta valves off the market

July 31, 2023 By Chris Newmarker The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early. In a statement shared with

July 31, 2023 By Chris Newmarker

The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early.

In a statement shared with MassDevice, the company said: “Abbott has decided to withdraw and discontinue its Trifecta family of valves to focus on its next-generation tissue valves that maximize possibilities for lifetime management of valvular heart disease.”

In a letter dated today and shared by the FDA, the company told U.S. health providers that it would collect its unused consigned inventory and assist in the returns of any customer-owned inventory.

The company added in its shared statement: “Abbott is initiating inventory-related activities worldwide for unused Trifecta and Trifecta GT valves, in accordance with respective regulatory frameworks.”

Back in late February, the FDA told health providers that published literature suggests a higher cumulative incidence of early structural valve deterioration (SVD) for Trifecta valves compared to other commercially available valves. The definition of early, in this case, was five years or less.

Abbott said in the letter to health providers: “The assessment of incidence and risk associated with early SVD has not changed since the February communication. Abbott continues to work closely with the FDA on post-market surveillance associated with prior implants.”

The full letter from Abbott is on the company’s website.

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Abbott