Abbott

Amanda Pedersen | Aug 01, 2023

In a move that comes about 5 months after FDA raised durability concerns about Abbott's Trifecta heart valves, the company has permanently withdrawn the devices from the market.

FDA alerted healthcare providers in late February about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves including the Trifecta with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. According to the agency, published literature suggests a higher cumulative incidence of early (five years or less) SVD for Trifecta valves compared to competing surgical aortic valves.

"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," Brent Tippen, an Abbott spokesperson at Abbott, said in a statement shared with MD+DI. "Abbott is initiating inventory-related activities worldwide for unused Trifecta and Trifecta GT valves, in accordance with respective regulatory frameworks."

FDA approved the first-generation Trifecta valve, which has not been on the market in some time, in 2011. The agency approved the Trifecta GT valve in 2016. Abbott inherited the products when it acquired St. Jude Medical in 2017.

The agency said it routinely evaluates adverse event reports and published literature to monitor the safety and effectiveness of medical devices. Published studies suggest a higher cumulative incidence of early SVD and lower freedom from reintervention due to SVD associated with Trifecta valves.

The published literature includes results combined for the Trifecta and Trifecta GT valves, and the patient management considerations provided by Abbott apply to both Trifecta valve models, FDA noted.

The agency said it has also received medical device reports that describe early SVD with Trifecta valves, with reports showing a peak time to SVD of three to four years post-implant. Reported outcomes include surgical valve explant/replacement, transcatheter valve-in-valve intervention, and in some cases death.

For patients in need of an aortic valve replacement, transcatheter aortic valve replacement (TAVR) is generally preferred over surgical aortic valve replacement (SAVR), except in cases where the patient has unfavorable anatomy in the TAVR implantation zone or poor femoral access.

So, while Abbott's structural heart business has been a bright spot in the company's recent earnings reports, the discontinuation of the Trifecta valves is unlikely to dim the overall structural heart business for Abbott.

In January, FDA approved Abbott's newest transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The Navitor system, which Abbott won a CE mark for in 2021, is designed with a unique fabric cuff to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak. MD+DI spoke with Santosh Prabhu, divisional vice president of product development, in February to learn more about the design considerations and challenges involved with bringing the Navitor system to market.

In 2021, Frontiers in Cardiovascular Medicine published an analysis of SAVR and TAVR trends from 2011 (when FDA first approved TAVR procedures) through 2017. Use of SAVR showed a downward trend during the period of 2015 through 2017 as TAVR use increased. Higher in-hospital mortality was recorded in patients who underwent SAVR, the researchers noted. In 2019 TAVR exceeded all forms of surgical aortic valve replacement (SAVR) for the first time, according to a 2020 report published in the Journal of the American College of Cardiology and The Annals of Thoracic Surgery simultaneously.

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