Home Medizin FDA genehmigt ersten Transkatheter-Trikuspidalklappenersatz

FDA genehmigt ersten Transkatheter-Trikuspidalklappenersatz

von NFI Redaktion

Edwards Lifesciences has received US Food and Drug Administration (FDA) approval for its Evoque tricuspid valve replacement system. This is the first transcatheter therapy approved in the United States for the treatment of tricuspid valve insufficiency.

The Evoque system is indicated for improving the health status of patients with symptomatic severe tricuspid insufficiency despite optimal medical therapy, where tricuspid valve replacement is deemed appropriate by a heart team, according to the announcement.

The availability of a transcatheter therapy for tricuspid valve replacement provides an option for elderly patients with severe tricuspid insufficiency for whom the risk of surgery may be too high.

The Evoque system, which previously received breakthrough status from the FDA, consists of a self-expanding nitinol frame, an intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. The Evoque valve will be available in three sizes, all delivered via the same transfemoral 28F system.

„Patients suffering from tricuspid insufficiency experience life-limiting symptoms and have had no approved transcatheter treatment options until today,“ said Susheel Kodali, MD, Director of the Structural Heart and Valve Center at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, NY.

Kodali was the lead investigator of the TRISCEND II study, which demonstrated the superiority of the Evoque system compared to optimal medical therapy alone. Key findings from the 6-month study, presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, included a significant reduction or elimination of tricuspid insufficiency, as well as a significant and sustained improvement in quality of life, while demonstrating a favorable risk-benefit ratio, according to Edwards Lifesciences.

In addition to the 6-month cohort, 318 of the total 392 randomly assigned patients underwent a 1-year follow-up. The results showed favorable trends in the device group compared to the control group for the primary composite endpoints, including all-cause mortality, tricuspid intervention, hospitalization due to heart failure, and quality of life.

Edwards Lifesciences expects to present the complete cohort of 392 patients from the TRISCEND II pivotal study at the TCT meeting later in 2024.

The Evoque system received CE marking in Europe in October 2023.

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