Trifecta Heart Valves Pulled From U.S. Market by Abbott

Abbott announced that it is withdrawing all of its Trifecta heart valves from the U.S. market and removing the remaining inventory from the field due to early structural valve deterioration (SVD).

The July 30 letter to Abbott customers, reiterated Abbott and the FDA’s February concerns about the Trifecta Valve and the Trifecta Valve with Glide Technology. “The assessment of incidence and risk associated with early SVD has not changed since the February communication,” Abbott stated in the letter.

Abbott said it decided to discontinue the Trifecta valves to focus on tissue heart valve solutions that maximize possibilities for lifetime management of valvular heart disease.

The company told customers to return any inventory that is not implanted and report any adverse reactions or quality problems to Abbott or the FDA.

Read the FDA’s letter to healthcare providers here.

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