Edwards Lifesciences has reported positive results from the RHEIA trial, which focused on evaluating outcomes for women undergoing transcatheter aortic valve implantation (TAVI).
Researchers have revealed that women receiving the Edwards SAPIEN 3 or SAPIEN 3 Ultra valves achieved superior results compared to those who underwent surgical aortic valve replacement (SAVR).
In assessing composite one-year endpoints, TAVI demonstrated superior results compared to SAVR.
According to RHEIA’s data, 8.9% of TAVI patients experienced death, stroke, or rehospitalisation, compared to 15.6% in the SAVR group.
The independently conducted trial included 443 female patients, averaging 73 years of age, who were randomly assigned to either TAVI or SAVR.
RHEIA aimed to evaluate the performance of Edwards TAVI devices against surgical alternatives in women with severe symptomatic aortic stenosis.
Sponsored by US-based Edwards Lifesciences and initiated by investigators, the RHEIA trial was carried out across 48 sites in 12 European countries.
Edwards Lifesciences corporate vice president and transcatheter aortic valve replacement and surgical structural heart group president Larry Wood said: “We are proud of this high-quality clinical research to inform patients’ decisions about the treatment of their heart valve failure.
“The outstanding success of the TAVI group points to the importance of valve selection for women undergoing aortic valve replacement – especially those women with small annuli – to preserve their options for a future valve-in-valve procedure, ensuring the lifetime management of their disease.”
In June, Edwards Lifesciences announced five-year data supporting the use of its transcatheter aortic valve replacement (TAVR) in women and patients with a small annulus.
The results from the PARTNER trials highlighted the durability of the valve over a five-year follow-up period, regardless of the patient’s annulus size or sex.
Recently, the medical technology firm agreed to acquire JC Medical, a subsidiary of Genesis MedTech. The transaction includes the intellectual property and commercial rights to JC Medical’s J-Valve system.
Other recent acquisition deals that Edwards Lifesciences has completed include JenaValve Technology and Endotronix, Bio Medical, among others.
