Edwards excites with Evoque FDA approval in transcatheter tricuspid valve replacement

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来源: FierceBiotech

Data from a randomized, controlled trial of the Evoque presented at Transcatheter Cardiovascular Therapeutics 2023 showed that out of 150 patients, 98.8% saw their tricuspid regurgitation reduced to at least the “moderate” grade after six months.

Edwards Lifesciences has claimed the FDA’s first approval of a transcatheter replacement implant for a leaky tricuspid heart valve, three months after garnering a green light in Europe.

The Evoque, with its self-expanding frame and edge-sealing skirt, is designed to address severe tricuspid regurgitation that persists despite previous medical treatments.

“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” said Susheel Kodali, M.D., principal investigator of the implant’s pivotal trial, dubbed TRISCEND II, and director of the Structural Heart and Valve Center at the Columbia University Irving Medical Center and New York-Presbyterian Hospital.

“The Evoque system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients,” Kodali said in a statement. “We see significant improvements in patients’ symptoms and quality-of-life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients.”

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Data from the randomized, controlled trial were presented last October at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) conference. Out of 150 patients, 98.8% saw their tricuspid regurgitation levels reduced to at least the “moderate” category after six months, while 93.8% reached at least the “mild” grade. The company said it plans to present the full data from TRISCEND II’s 392 patients later this year at TCT 2024 in Washington, D.C.

Edwards received a CE mark in Europe that same month, marking the first regulatory approval for a minimally invasive therapy to tackle the historically tricky tricuspid valve. With its set of three flaps separating the right ventricle and atrium, it has posed special challenges compared to the heart’s aortic and mitral valves. Variations in the tricuspid valve’s anatomy can also carry risks in open heart surgery, where the procedure is limited to certain situations in major cardiology guidelines.

In Europe, Evoque is cleared along with Edwards’ cliplike Pascal repair system, designed to hold the tricuspid valve’s flaps together to form a tighter seal and prevent the backflow of blood that causes regurgitation—as well as the Cardioband, which helps reshape the outer ring of the valve. Pascal and Cardioband have not yet been approved by the FDA for the tricuspid valve.

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