Edwards announces ‘successful results’ from TRISCEND II trial

Edwards Lifesciences announced “successful results” from TRISCEND II, a randomized controlled pivotal trial designed to evaluate the safety and effectiveness of the EVOQUE tricuspid valve replacement system with optimal medical therapy, or OMT, compared to OMT alone with 2:1 randomization. The outcomes for the first 150 patients of the TRISCEND II trial achieved the primary safety endpoint at 30 days and both co-primary effectiveness endpoints at six months, demonstrating superiority to OMT alone. Results from the TRISCEND II trial were presented as a late-breaking clinical trial session at the 35th Transcatheter Cardiovascular Therapeutics, or TCT, the annual scientific symposium of the Cardiovascular Research Foundation. “An FDA Advisory Committee Meeting of the EVOQUE system is expected in Jan. 2024, followed by an anticipated US approval in mid-2024. In 2019, the EVOQUE system received FDA Breakthrough Designation, which is designed to provide patients with timely access to new devices for life-threatening or irreversibly debilitating conditions. As a result, the TRISCEND II trial was specifically designed to include a pre-specified analysis of the first 150 patients enrolled to evaluate the safety and effectiveness of the EVOQUE system. The full cohort of 400 patients is enrolled. Earlier this month, the EVOQUE system received CE Mark for the transcatheter treatment of eligible patients with TR,” the company stated.