Edwards Lifesciences has shown strong support for the new ESC and EACTS guidelines for treating valvular heart disease. These updated guidelines suggest a simpler and more active approach for managing severe aortic stenosis in all patients, including those who aren’t showing any symptoms. This represents a big change from the earlier “watch and wait” method, and it encourages treating patients earlier, even if they feel fine. The guidelines also lower the age limit for TAVR to 70, showing more confidence in the long-term safety and effectiveness of the procedure.
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Right now, Edwards is the only company with approval for using TAVR to treat severe aortic stenosis in people who don’t have symptoms in both the US and Europe. The EARLY TAVR trial gave important data that influenced these new guidelines and also helped get the Edwards SAPIEN 3 platform approved for a broader range of patients. The SAPIEN 3 Ultra RESILIA valve is part of this platform and offers a proven solution for long-term care. Over the past 20 years, more than one million patients have been treated using the SAPIEN platform, making it the most studied TAVR technology globally.
The updated guidelines also give more support for catheter-based treatments for mitral and tricuspid valve issues. At ESC Congress 2025, Edwards shared positive results from the TRISCEND II study, which looked at the EVOQUE transcatheter tricuspid valve replacement system. The study found that after 18 months, the EVOQUE system significantly reduced hospital visits for heart failure in patients with severe tricuspid regurgitation. One year later, patients who got the EVOQUE treatment still had better results than those who only got standard medical care, including consistent removal of tricuspid regurgitation.
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EVOQUE is the first and only transcatheter tricuspid valve replacement system approved in both the US and Europe. Its rising use shows the growing importance of addressing right-sided heart valve problems with less invasive options. Edwards views these guideline changes as a sign of growing trust in these types of treatments from the medical community.
Bernard Zovighian, CEO of Edwards Lifesciences, commented that these updates represent a major progress for people with structural heart disease. He added that with new data, broader treatment options, and revised recommendations, the industry is better equipped to improve patient outcomes, increase access to care and reduce the workload on healthcare systems.
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