Edwards Lifesciences (EW) announced its SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive FDA approval for the treatment of mitral regurgitation. The system is indicated for patients deemed unsuitable for surgery or transcatheter edge-to-edge repair therapy. The approval is based on one-year data from the ENCIRCLE pivotal trial, which showed significant mitral regurgitation elimination and improvements in symptoms.
Claim 70% Off TipRanks This Holiday Season
- Unlock hedge-fund level data and powerful investing tools for smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on EW:
- Edwards Lifesciences Advances Smart Surgery Monitoring With Completed SMART TRENDS Study
- Edwards Lifesciences upgraded to Overweight from Neutral at JPMorgan
- Edwards Lifesciences: Buy Rating on Structural Heart Leadership, Accelerating TAVR/TMTT Growth, and Durable Double‑Digit Upside
- Edwards Lifesciences price target lowered to $87 from $89 at Canaccord
- Positive Outlook for Edwards Lifesciences Amid CMS Coverage Expansion for TAVR Procedures