Transcatheter therapy system becomes first to earn FDA approval for treating tricuspid regurgitation

Editor's Note

Patients with severe cases of tricuspid regurgitation (in which a critical heart valve fails to close properly) now have a new treatment option thanks to the recent US Food and Drug Administration (FDA) approval of the ENVOQUE tricuspid valve replacement system, according to a February 2 press release from manufacturer Edwards Lifesciences Corporation.

According to the announcement, the system is the first transcatheter therapy to receive FDA approval for treatment of tricuspid regurgitation. “The EVOQUE system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients,” said Susheel Kodali, MD, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and a principal investigator on the TRISCEND II study that evaluated the system. “We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves.”

The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), for whom tricuspid valve replacement is deemed appropriate by a heart team. It consists of a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s proven bovine pericardial tissue. The EVOQUE valve will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.