- Abbott is withdrawing its Trifecta family of heart valve replacements from the U.S. in response to evidence that the products deteriorate faster than rival devices.
- The U.S. Food and Drug Administration and Abbott wrote to healthcare providers about the data on the rate of early structural valve deterioration (SVD) in February. Now, Abbott has decided to remove “the limited remaining inventory” from the field, the company said in a Monday letter to customers.
- Abbott framed the action, which removes a competitor to Edwards Lifesciences and Medtronic, as enabling it to focus on products that “maximize possibilities for lifetime management of valvular heart disease.”
Abbott’s Trifecta devices are intended to treat damaged or malfunctioning aortic heart valves.
St. Jude Medical won approval for the first-generation Trifecta device in 2011 and launched its follow-up product, Trifecta GT, five years later. Abbott continued to sell the surgical aortic valve replacement (SAVR) devices after buying St. Jude in 2017 and recently reviewed 21 articles about the durability of the Trifecta products.
Based on the studies, Abbott said “there appears to be a higher early and midterm cumulative incidence of SVD, and a lower freedom from early and midterm reintervention due to SVD for the Trifecta valve.”
Initially, Abbott shared advice with healthcare professionals and continued studying the problem.
Five months later, Abbott has decided to withdraw the products from the U.S. market. Most of the SVD data comes from recipients of the first-generation Trifecta device, which Abbott had discontinued, but the results for Trifecta GT are similar. Abbott’s assessment of the risk of SVD is unchanged from its earlier notice and the FDA has kept the recommendations it made in February.
Abbott competes for the market with companies including Edwards and Medtronic, which respectively sell the Magna Ease and Freestyle valves. While Abbott is retreating from Trifecta, it continues to work on heart valve products with the goal of achieving the “lifetime management of valvular heart disease.”