Edwards Lifesciences has claimed a groundbreaking approval from the FDA that opens up its minimally invasive heart valve implants to patients before they begin to show cardiac symptoms.
The company said that as many as one in 10 patients with severe, restrictive narrowing of the heart’s aortic valve may die within five weeks if the condition is left untreated. On top of that, aortic stenosis symptoms may be difficult to detect and progress rapidly.
The current standard of care, however, is watchful waiting before planning a procedure—careful surveillance of the patient with regular echocardiograms, while monitoring to see if they begin to develop chest pain, shortness of breath, or other signs of cardiac problems.
The FDA issued the new approval to Edwards’ Sapien 3 family of transcatheter aortic valve replacement implants, including the Sapien 3 Ultra and Resilia, based in part on data from a randomized clinical trial that showed earlier interventions could help avoid earlier deaths, strokes, trips to the hospital and declines in a patient’s quality of life.
That study, dubbed EARLY TAVR, was the first of its kind, and was spotlighted last October as a late-breaking trial at the TCT conference last fall and published in the New England Journal of Medicine.
“There is an urgent need to change practice and TAVR guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” said one of the study’s authors, Philippe Généreux, director of the structural heart program at Gagnon Cardiovascular Institute in New Jersey.
“As we saw in the EARLY TAVR trial, patients originally designated as asymptomatic became symptomatic in sudden and unpredictable ways, underscoring the importance of early evaluation by a heart team to improve patient outcomes and benefit the healthcare system,” Généreux said in a statement.
The trial followed more than 900 participants for a median of 3.8 years. In that time, 26.8% of patients in the TAVR arm experienced either death, a stroke or a cardiovascular hospitalization, compared to 45.3% among those undergoing clinical surveillance—the most significant difference being hospitalizations.
In the latter group, which had check-ups every six to 12 months, more than 87% eventually had their heart valves replaced—including about 25% of participants within the first six months of the study. Procedures were scheduled about 32 days after symptoms developed, on average, and the vast majority underwent a TAVR procedure. There were also no apparent differences in procedural complications between the two study arms.
The company followed up with additional data from EARLY TAVR and asymptomatic aortic stenosis patients at the annual meeting of the American College of Cardiology in late March, showing that certain cardiac biomarkers were not necessarily predictive of the need for a more rapid intervention
On the company’s first-quarter earnings call last month, CEO Bernard Zovighian said that expanding Edwards’ TAVR portfolio into asymptomatic patients represented a “multi-year growth opportunity,” which would balloon as treatment guidelines and physician perspectives begin to evolve in the U.S. and globally.
“The minute we get the indication approved, we have a very detailed education plan,” Edwards’ TAVR and structural heart group president, Larry Wood, said on the April 23 investor call. “We can then begin reaching out to the referral base and doing all of the other things that we want to do to help amplify this message.”
The company is also studying TAVR interventions in patients with moderate-grade aortic stenosis, with results expected in late 2026.