Edwards Lifesciences has revealed positive data from two real-world studies evaluating its SAPIEN valve platform.

The first study observed the outcomes of over 10,000 patients across the US treated with the SAPIEN 3 Ultra RESILIA valve, compared with the SAPIEN 3 Ultra and SAPIEN transcatheter aortic valves – prosthetic valves inserted through a catheter to treat patients with damaged aortic valves. After 30 days, the SAPIEN 3 Ultra RESILIA valve found lower rates of paravalvular leak (PVL), with 88.3% of patients experiencing no PVL at all.

In the second study, a three-year analysis of 8,100 patients treated with smaller 20mm SAPIEN valves demonstrated good all-cause mortality and stroke outcomes, equivalent to patients receiving larger 23, 26, and 29mm SAPIEN valve sizes.

The SAPIEN 3 Ultra RESILIA valve launched in the US at the end of 2022, following approval from the US Food and Drug Administration (FDA). According to a forecast model on GlobalData’s Medical Intelligence Center, the transcatheter aortic valve replacement (TAVR) market in the US will reach $4.7bn by 2030.

GlobalData is the parent company of Clinical Trials Arena.

In the announcement accompanying the data, corporate vice president of Edwards Larry Wood said: “These real-world data further add to the robust body of evidence on the performance of Edwards SAPIEN TAVR and highlight the meaningful advancements of the SAPIEN 3 Ultra RESILIA valve, which provides patients with severe aortic stenosis the leading option for true lifetime management of their heart valve disease.”

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The company gained approval from the FDA in February 2024 for its EVOQUE tricuspid valve replacement system, a transcatheter therapy, for treating symptomatic severe tricuspid regurgitation.

The company were the subject of controversy last year, following unannounced raids by the EU commission in September 2023. The raid was conducted as part of an investigation into abuses and breaches of EU antitrust regulations, related to Article 102 of the Treaty on the Functioning of the European Union, which prohibits abuses of a dominant market position. Edwards responded at the time, stating that it would work with the EU and remains committed to healthy, fair, competition.

Edwards reported net sales of $6bn in 2023, growing 12% from 2022 at $5.4bn, as per the company’s financials.