Edwards Lifesciences tricuspid valve reduced leakage in nearly all patients
Edwards Lifesciences‘s Evoque tricuspid valve replacement system reduced tricuspid heart valve leakage to non-traceable or mild leakage in 98% of patients, a small study showed.
Evoque is designed to replace native tricuspid valves without open-heart surgery. The surgeon implants the valve using a minimally invasive delivery system by placing a thin tube through a vein in the leg to reach the patient’s heart.
The study included 56 patients with an average Kansas City Cardiomyopathy Questionnaire overall summary score of 46 at baseline, indicating severe disability. The score improved by 19 points at 30 days with the Evoque device. Walk distance also improved by 46 meters after device intervention.
Edwards’s trial had a composite major adverse event rate of 22.6% with 1 cardiovascular death, 2 non-elective tricuspid re-interventions, 1 major access site/vascular complication and 12 severe bleeding events that were non-life-threatening or fatal, according to the study.
The company plans to add more patients to the Triscend study and continue to evaluate the patients at six months, one year and annually for five years.