FDA warns of potential early deterioration of Abbott Trifecta devices
28 Feb 2023
Drug Approval
The Trifecta and Trifecta GT valves are heart valve replacement devices that treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves
The FDA has issued an alert regarding a potential risk of early SVD with Abbott’s Trifecta valves. (Credit: Abbott)
The US Food and Drug Administration (FDA) has issued an alert regarding a possible risk of early structural valve deterioration (SVD) with Abbott’s Trifecta family of bioprosthetic heart valves.
The alert has been issued for the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which feature leaflets mounted externally to the valve frame.
Trifecta Valve and Trifecta GT are heart valve replacement devices that are designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves.
According to the FDA, the data from published literature shows a higher cumulative incidence of SVD within five years for Trifecta valves compared to other existing surgical bioprosthetic valves in the market.
The literature compared the durability of Trifecta valves to other available bovine pericardial valves across different time points after the implant.
These findings point to a higher cumulative incidence of early SVD and a lower freedom from reintervention as a result of SVD linked to Trifecta valves, the US health regulator added.
The results combined for the Trifecta and Trifecta GT valves, and the patient management considerations provided by Abbott apply to the two Trifecta valve models.
The FDA said that it has received medical device reports (MDRs) describing early SVD with Trifecta valves. These studies indicate that SVD peaked three to four years after implant.
The US health regulator said: “Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death.”
The FDA stated that it is collaborating with Abbott to further analyse the problem and provide new patient management strategies, if required.
Additionally, it will continue monitoring the literature and reports of adverse incidents and will inform the public whenever any fresh information or suggestions is available.
US-based Abbott has also issued a letter to healthcare professionals with steps to better detect SVDs.
The first-generation Trifecta valve, which was initially authorised in 2011, is no longer sold in the US. In 2016, the Trifecta GT valve also received approval.
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