EW - FDA Advisors Set To Discuss Abbott's TriClip For Heart Valve Disorder As Questions On Pivotal Trial Loom | Benzinga
On Tuesday, February 13, 2024, the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet regarding the premarket approval application (PMA) for Abbott Laboratories (NYSE:ABT) TriClip G4 System.
The TriClip G4 System is indicated for patients with symptomatic severe tricuspid regurgitation (TR) despite being treated optimally with medical therapy, who are at intermediate or greater risk for surgery, and in whom tricuspid valve edge-to-edge repair (TEER) is appropriate.
TR is a type of heart valve disease that occurs when the valve’s flaps (cusps or leaflets) do not close properly, potentially causing heart failure.
On Friday, the committee released ...