Irvine, California–based Edwards presented the data during the late-breaking clinical science session at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), according to a news release.
The study evaluated 132 patients (56 patients with six-month follow-up) treated with Evoque for symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR), despite optimal medical therapy at six months. It demonstrated TR reduction by core laboratory assessment, with 100% of patients experiencing none/trace or mild TR in 43 patients with paired echocardiographic data available.
Evoque also significantly improved functional and quality of life outcomes, including 89% of patients in NYHA Class I or II, and a 27-point increase in KCCQ score over baseline. There was a high survival rate of 96%, and 94% of patients evaluated experienced freedom from heart failure hospitalization.
The study continues to enroll and additional patient follow-up will take place at one year and annually up to five years. Evoque remains an investigational device and is not available for sale in any country.
“We are quite encouraged by these data, not only related to the therapy and procedural success rates demonstrated by the Evoque system, but also for the significant TR reduction and sustained improvements in quality-of-life measures experienced by patients,” Edwards Corporate VP of Transcatheter Mitral & Tricuspid Therapies Bernard J. Zovighian said in the release.
Zovighian added: “We are committed to building a strong body of evidence to support emerging therapies like the Evoque system, which will continue with our randomized pivotal trial, Triscend II, currently underway.”