FDA Approval: Evoque Valve for Tricuspid Regurgitation

Edwards Life sciences Corporation, a global leader in patient-centered innovation for cardiovascular design and critical care monitoring, announced that the company's Evoque tricuspid valve replacement system is the first percutaneous therapy approved in the US. Food and Drug Administration (FDA) for tricuspid valve repair. Reflux (TR).

The Evoque System is indicated to improve the health status of patients with symptomatic TR despite excellent medical therapy (OMT) and when tricuspid valve replacement is required—cardiac group.

"Edwards has a long history of driving innovation and pioneering new treatments to address the unmet needs of patients with structural heart disease," said Daveen Chopra, executive vice president of mitral and tricuspid valve treatments at Edwards. "We are grateful for the strong collaboration with physicians worldwide who have had the opportunity to now produce the Evoque system through the FDA's Breakthrough pathway to provide a treatment option for many patients in the United States with tricuspid valve disease."

The Evoque system includes an expandable Nitinol frame, an annular sealing skirt, and tissue sheets from proven bovine pericardial tissue. The Evoque quad is available in three sizes, all delivered via the compact 28F transfemoral system.

"Patients with tricuspid regurgitation suffer from life-threatening symptoms, and to date, percutaneous treatment options have not been approved," said Susheel, director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/Nova York - Presbyterian Kodali. Said Hospital and principal investigator of the TRISCEND II study. “The Evoque system can replace the primary tricuspid valve, eliminating tricuspid regurgitation in many patients. We confirmed a significant improvement in the patient's symptoms and quality of life, including taking care of him without shortness of breath. The highest patient preference study was conducted among patients in the large TRISCEND II trial.