New research by Edwards Lifesciences has demonstrated that early intervention for severe aortic stenosis (AS) before symptoms develop improves patient outcomes and reduces the economic and resource burden on healthcare systems.
Edwards’ real-world study of more than 24,000 patients with severe AS demonstrated that prompt intervention resulted in an average of 2.2 fewer days spent in hospitals during patients’ treatment, 80% fewer heart failure hospitalisations one year after treatment, and cost reductions of $36,000 per patient at the one-year point.
Go deeper with GlobalData
The study results were presented as a late-breaking clinical trial at EuroPCR 2025, taking place in Paris, France, between 20 and 23 May.
Larry Wood, Edwards’ corporate vice president and transcatheter aortic valve replacement (TAVR) and surgical group president, said: “We are dedicated to advancing robust evidence to help improve outcomes for patients with severe AS.
“These latest findings underscore the importance of early referral to a heart valve team and timely care of patients with severe AS, reducing the economic and resource burden for hospitals.”
It is no surprise that Edwards is shining a light on early AS intervention. The medtech giant recently received approval from the US Food and Drug Administration (FDA) on an indication expansion for its SAPIEN 3 TAVR platform in the treatment of patients with asymptomatic severe AS.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe approval was supported by data from Edwards’ EARLY TAVR trial (NCT03042104). The results demonstrated that asymptomatic severe AS patients randomised to the company’s TAVR experienced superior outcomes versus guideline-recommended clinical surveillance (watchful waiting).
At a median follow-up of 3.8 years, the data showed that 26.8% of the 455 patients in the trial’s TAVR arm experienced death, stroke or unplanned cardiovascular hospitalisation versus 45.3% of the 446 patients in the clinical surveillance arm.
According to GlobalData analysis, the global TAVR market is forecast to reach a valuation of around $13.7bn by 2033, up from $6.16bn in 2023.
GlobalData’s US Healthcare Facility Invoicing Database indicates that Edwards Lifesciences is currently the TAVR market leader, holding more than a 60% share of the US TAVR market. But change may be afoot.
Medtronic recently released two-year results from a clinical trial comparing its Evolut system to Edwards’ SAPIEN, with the data showing that the Evolut system led to significantly less bioprosthetic valve dysfunction, five times less prosthetic valve thrombosis, and nine times less haemodynamic structural valve dysfunction than the SAPIEN system.
According to GlobalData analysis, the Evolut system could become the preferred option among healthcare professionals for patients with symptomatic severe AS and small aortic annulus categories, as evaluated in the trial.
