Federal health officials have issued a warning about certain heart valve replacement devices made by Abbott. These devices, called the Trifecta Valve and the Trifecta Valve with Glide Technology, may deteriorate much faster than other similar devices. This could lead to patients needing another surgery to replace the valve sooner than expected or even experiencing serious and life-threatening health problems.
The Trifecta and Trifecta GT valves are used to treat people with heart valve problems, specifically with the aortic heart valve, which is an important valve that helps the heart function properly. The valves are intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
The FDA approved the first-generation Trifecta valve in 2011, but it is no longer sold – with good reason – in the United States. The Trifecta GT valve, which was approved in 2016, is currently the only Abbott heart valve replacement device still available in the United States. It was approved with the hope that this new tissue valve would offer enhancements that would make the implantation process smoother, providing a solution to patients, even those with more challenging cases.