FDA Approves Abbott’s Heart Valve Repair Device, TriClip

Abbott Laboratories has received U.S. FDA approval for TriClip, a heart valve repair device designed to treat tricuspid regurgitation (TR). In this condition, the heart’s valve does not close properly, causing blood to flow backward. This approval follows a similar nod given to a rival device by Edwards Lifesciences. TR affects an estimated 1.6 million Americans, often older individuals with other health issues, making them at high risk for open-heart surgery complications. Unlike Edwards Lifesciences’ valve replacement device, Abbott’s TriClip repairs the tricuspid valve by clipping its flaps to reduce blood backflow. The device, part of Abbott’s “Fab 5” devices expected to drive future sales growth, is inserted via the femoral vein and approved in over 50 countries. According to Abbott, 98% of TriClip recipients experienced no significant adverse events within 30 days, highlighting its safety and effectiveness as a treatment option.

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[Source: Reuters, April 2nd, 2024]