Edwards Lifesciences has announced that the US Food and Drug Administration (FDA) has approved its Sapien 3 transcatheter aortic valve implantation (TAVI) platform for the treatment of severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVI in asymptomatic patients.
Approval of the Sapien 3 platform (Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia) is based on data from the EARLY TAVR trial, in which it was demonstrated that asymptomatic severe AS patients randomised to TAVI with Sapien 3 experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting).
“There is an urgent need to change practice and TAVI guidelines for the treatment of aortic stenosis patients, which currently recommend ‘watchful waiting’ until symptoms develop,” said Philippe Genereux (Morristown Medical Center, Morristown, USA), the principal investigator in the EARLY TAVR trial. “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.”
The EARLY TAVR trial was the first randomised, controlled trial designed to evaluate TAVI compared to watchful waiting for patients with asymptomatic severe AS. With a median follow-up of 3.8 years, 26.8% of the 455 patients in the TAVI arm experienced death, stroke, or unplanned cardiovascular hospitalisation, compared with 45.3% of the 446 patients in the clinical surveillance arm. The data were published last year in The New England Journal of Medicine (NEJM), after having been presented at TCT 2024 (27–30 October, Washington, DC, USA).
“This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” said Larry Wood, Edwards’ corporate vice president and group president, Transcatheter Aortic Valve Replacement and Surgical. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimise the treatment pathway for patients.”
