December 23, 2025
1 min read
Key takeaways:
- A transseptal mitral valve replacement system was approved for patients unsuitable for surgery or transcatheter edge-to-edge repair.
- Approval was based on the results of the ENCIRCLE trial.
Edwards Lifesciences announced its transseptal mitral valve replacement system received FDA approval for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation.
The femoral-delivered mitral valve replacement system (Sapien M3) is indicated for patients unsuitable for surgery or transcatheter edge-to-edge repair therapy, according to a company press release.
The system is also indicated for patients with symptomatic mitral valve dysfunction associated with mitral annular calcification who are unsuitable for surgery or transcatheter edge-to-edge repair therapy, according to the release.
Approval was based on the positive 1-year data from the ENCIRCLE trial presented at TCT 2025 and simultaneously published in The Lancet.
A total of 299 patients participated in the ENCIRCLE trial, of which 81% had follow-up data at 1 year (median age, 77 years; 51% men).
Researchers reported that transseptal mitral valve replacement was associated with significant mitral regurgitation elimination and improvement in symptoms and quality-of-life, with no intraprocedural deaths, left ventricular outflow tract obstruction or conversion to surgery.
“Mitral regurgitation is very common among valvular heart diseases, and these patients often present with debilitating symptoms that are life-threatening and significantly diminish their quality-of-life. Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering,” David Daniels, MD, cardiologist at Sutter West Bay Medical Group and structural heart section chief of Sutter’s Heart & Vascular Service Line, said in the release. “The SAPIEN M3 system’s ability to provide a fully percutaneous mitral valve replacement that safely delivers near elimination of significant mitral regurgitation and meaningfully improves their symptoms is a game-changer for these patients.”
Sources/Disclosures
Source:
Press Release
References:
Disclosures:
Daniels reports consulting for Edwards Lifesciences.
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