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FDA approves Edwards Lifesciences' tricuspid valve replacement system

In a major development, US-based global leader of patient-focused innovations for structural heart disease and critical care monitoring, Edwards Lifesciences Corporation has recently announced that the company has achieved a significant accomplishment by gaining approval from the U.S. Food and Drug Administration (FDA) for its EVOQUE tricuspid valve replacement system. This is a breakthrough in treating tricuspid regurgitation (TR) in patients with structural heart disease.

The EVOQUE system is designed for patients with severe TR symptoms despite optimal medical therapy, where tricuspid valve replacement is deemed suitable by a heart team. Daveen Chopra, Edwards' Corporate Vice President, expressed gratitude for the collaborative effort with clinicians worldwide and highlighted the company's commitment to innovation in addressing structural heart disease.

The EVOQUE valve, consisting of a nitinol frame, sealing skirt, and tissue leaflets, will be available in three sizes. Importantly, all sizes can be delivered through the same low-profile transfemoral 28F system, making it versatile in application.

Dr Susheel Kodali, Director of the Structural Heart and Valve Centre at Columbia University Irving Medical Centre, noted that patients with tricuspid regurgitation often face debilitating symptoms. The EVOQUE system, by replacing the native tricuspid valve, offers a transcatheter treatment option that significantly reduces or eliminates tricuspid regurgitation. Results from the TRISCEND II pivotal trial demonstrated the EVOQUE system's superiority over optimal medical therapy alone, showing favourable safety and effectiveness outcomes.

The pivotal trial, presented at TCT 2023, highlighted a substantial reduction or elimination of tricuspid regurgitation and a sustained improvement in quality of life. The trial showcased the EVOQUE system's ability to balance risk and benefit.

After receiving CE Mark approval in October 2023, the EVOQUE system became the world's first transcatheter valve replacement therapy with regulatory approval for treating TR. Edwards Lifesciences remains committed to driving patient-focused innovations for structural heart disease and critical care monitoring through global healthcare partnerships, aiming to enhance lives worldwide.

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