Edwards Life says pivotal study for Evoque hit one-year goal

Edwards Lifesciences (NYSE:EW) announced Wednesday that its pivotal TRISCEND II trial for its Evoque tricuspid valve replacement (TTVR) system reached its one-year primary endpoint in patients with tricuspid regurgitation (TR), a heat value disease.

Evoque, the world’s first and only approved TTVR system, was successfully inserted into 95.4% of patients who took part in the trial, the Irvine, California-based MedTech said.

Out of those who received Evoque, 95.3% witnessed almost complete elimination of TR compared to 2.3% who were on placebo, the company announced, adding that the TR reductions were linked to significant improvements in measures such as quality of life.

There were numerically favorable outcomes related to mortality and heart failure hospitalization, Edwards Lifesciences (NYSE:EW) noted.

The trial was designed to evaluate Evoque with optimal medical therapy (OMT) against OMT alone in nearly 400 patients with at least severe TR.

Data were presented at a medical conference on Thursday and simultaneously published in The New England Journal of Medicine.

However, in a subsequent research note, Barclays analyst Matt Miksic, who has an Overweight rating on EW, argued that the lack of statistical superiority for mortality outcome in TRISCEND II could be a positive for Abbott Laboratories (ABT).

“TRISCEND II shows superiority in TR reduction and quality of life for Evoque vs. OMT, trending toward mortality benefit but falls short of statistical superiority,” Miksic wrote.

Early this year, the FDA cleared Evoque for patients with severe TR despite OMT after six-month results from TRISCEND II demonstrated its superiority compared to OMT alone, meeting the study’s all primary endpoints.