FDA Warning on Abbott Trifecta Heart Valves

FDA has issued a letter to healthcare providers warning about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta heart valves, including the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets mounted to the valve frame.

“Information from published literature suggests a higher cumulative incidence of early (five years or less) SVD for Trifecta valves compared to other commercially available surgical bioprosthetic valves,” the letter says. “The FDA is working with the manufacturer to evaluate information from all available sources on this issue,” it says.

The heart valve replacement devices are intended to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. The first-generation Trifecta valve was approved in 2011 and is no longer marketed, and the Trifecta GT valve was approved in 2016.