Edwards Lifesciences (NYSE: EW) today announced data supporting the use of its transcatheter aortic valve replacement (TAVR) in women.
The PARTNER trials served as the pivotal trials for FDA approval of SAPIEN and expanded indications. Edwards’ latest data takes a look at the outcomes of TAVR from those trials in patients with small annulus, with a focus on women. Medtronic recently had similar positive outcomes from the SMART trial, a head-to-head study with Edwards.
Through five-year follow-up of more than 1,300 low- and intermediate-risk Sapien 3 valve patients, Edwards reported strong clinical outcomes and valve durability, irrespective of the patient’s annulus size or sex. The company presented its data at New York Valves 2024: The Structural Heart Summit.
Investigators examined contemporary patient data with long-term follow-up from the PARTNER 3 and PARTNER 2 S3i trials. They aimed to determine if higher 30-day mean gradients and rates of prothesis-patient mismatch (PPM) translated to poorer long-term outcomes of death, disabling stroke or heart failure related hospitalization.
The analysis revealed no association between clinical outcomes or valve durability and severe PPM or higher mean gradients. Overall, the cohort had extremely low rates of reintervention and high survival out to five years.
“The PARTNER series of robust pivotal trials, all of which included FDA oversight, rigorously followed more than 12,000 patients treated with Edwards Sapien valves rendering them excellent data from which to examine the totality of factors that contribute to valve durability and performance,” said Larry Wood, Edwards corporate VP and group president, TAVR and surgical structural heart. “These data are reassuring for patients and clinicians – particularly women who are more likely to receive a smaller valve – that the Sapien platform offers excellent survival and very low reintervention rates at five years.”
More on medtech’s women’s health focus
There has been a greater push by the medical device industry to bring more diversity to clinical trials. Federal agencies have also begun to take a more thoughtful look at health equity in the U.S.
President Joe Biden in March signed an executive order that would direct funds and actions toward expanding and improving research on women’s health. Biden’s executive order intends to integrate women’s health across the federal research portfolio, prioritize investments in women’s health research, galvanize new research on women’s midlife health and assess unmet needs to support women’s health research.
The initiative builds on First Lady Jill Biden’s announcement in February in which the Advanced Research Projects Agency for Health (ARPA-H) earmarked $100 million in funds to “fundamentally change” how the U.S. approaches and funds women’s health research.
In April, a Medtronic survey revealed a lack of awareness among women regarding heart valve disease and its risk factors. The study examined women’s perceptions and knowledge of risk factors, treatment patterns and preventative care practices related to heart valve disease.
Ultimately, the study results showed limited awareness, racial disparities, under-referral for diagnosis and treatment, barriers to seeking care and a preference for effective treatment.
The FDA also announced in April that it wanted to advance health equity through home-based care in a new initiative, called “Home as a Health Care Hub.”While the initiative doesn’t target women specifically, it does seek to address the longstanding disparities in healthcare access and outcomes by using home-based care.
Senior Editor Danielle Kirsh contributed to this report.
