Key Takeaways Edwards Lifesciences won FDA approval for SAPIEN M3, the first transseptal TMVR for mitral regurgitation.EW's system targets patients unable to undergo surgery or edge-to-edge repair by using a transseptal approach.One-year ENCIRCLE trial data showed 95.7% MR elimination, with strong safety and symptom improvement.Edwards Lifesciences (EW) announced that the FDA approved its SAPIEN M3 transcatheter mitral valve replacement system, making it the first minimally invasive, catheter-based treatmen ...