Edwards announces positive results for Evoque valve replacement system - Mass Device

The Evoque transcatheter tricuspid valve replacement system. [Image from Edwards Lifesciences]

Edwards Lifesciences (NYSE:EW) announced that one-year results from the TRISCEND survey demonstrated favorable outcomes.

TRISCEND, a single-arm, prospective, global, multi-center survey evaluates the Edwards Evoque system. Evoque, a transcatheter tricuspid valve replacement system, demonstrated favorable safety, efficacy and quality-of-life outcomes.

Edwards presented information during the late-breaking trials league astatine PCR London Valves 2022.

Patients enrolled successful the proceedings had symptomatic mean oregon greater functional oregon degenerative tricuspid regurgitation (TR). They had TR contempt optimal aesculapian therapy. The proceedings enrolled 176 patients. Edwards said successful a quality merchandise that this represents the largest dataset among transcatheter tricuspid valve replacement therapies.

The institution earlier reported affirmative 30-day and 6-month results. One-year outcomes demonstrated precocious endurance of 90.1% and precocious state from bosom nonaccomplishment hospitalization astatine 88.4%. Additionally, subjects showed important and sustained TR simplification with 97.6% of patients demonstrating mild oregon hint TR.

Evoque besides importantly improved functional and prime of beingness outcomes. Edwards reported 93% of patients successful NYHA Class I oregon II compared to 26% astatine baseline. The institution said it saw a 26-point summation successful KCCQ people implicit baseline.

Study provides “important support” for Evoque

“Tricuspid regurgitation is prevalent, undertreated and has a important interaction connected patients’ prime of life. With astir TR patients astatine precocious hazard for surgery, determination is simply a large request for an approved transcatheter valve replacement attraction option,” said Dr. Didier Tchetche, Clinique Pasteur, Toulouse, France, and TRISCEND survey co-primary investigator. “The one-year results for patients who received the Evoque tricuspid valve replacement arsenic portion of the TRISCEND survey supply important enactment for our assurance successful this therapy arsenic an enactment for patients who endure from tricuspid regurgitation.”

Evoque is an investigational device. Edwards presently does not connection it for merchantability successful immoderate country. Its TRISCEND II randomized pivotal proceedings remains underway.

“We are encouraged by the sustained information and show outcomes demonstrated by the EVOQUE strategy astatine 1 year, arsenic it represents a meaningful therapy successful our portfolio of transcatheter therapies being developed to assistance amended the quality-of-life for patients with tricuspid and mitral valve diseases,” said Bernard J. Zovighian, Edwards’ firm VP, transcatheter mitral and tricuspid therapies. “Edwards’ 8 information presentations included successful this year’s PCR London Valves programme present connected our semipermanent concern successful innovation and objective grounds procreation to conscionable the needs of patients and people a caller epoch for our company.”