FDA approves first transcatheter tricuspid valve replacement system
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Key takeaways:
- The FDA approved the first transcatheter tricuspid valve replacement system.
- The system is indicated for patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy.
The FDA approved the first transcatheter tricuspid valve replacement system for the treatment of symptomatic severe tricuspid regurgitation despite optimal medical therapy.
The transcatheter tricuspid valve replacement system (TTVR; Evoque, Edwards Lifesciences) is comprised of a nitinol self-expanding frame, intra-annular sealing skirt and leaflets from bovine pericardial tissue and will be available in three sizes, according to a press release from the company.
Approval is based on the positive 6-month results from the randomized controlled pivotal TRISCEND II trial, presented at TCT 2023.
As Healio previously reported, on top of optimal medical therapy, TTVR was feasible with a lower-than-expected safety event rate compared with optimal medical therapy alone in the first 150 patients enrolled.
The company anticipates reporting data on the full cohort of 392 participants in the TRISCEND II trial at TCT 2024, according to the release.
“Patients suffering with tricuspid regurgitation endure life-impairing symptoms and, until today, had no approved transcatheter treatment options,” Susheel Kodali, MD, director of the structural heart and valve center at Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, said in the release. “The Evoque system is able to replace the native tricuspid valve, virtually eliminating tricuspid regurgitation in a wide range of patients. 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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