Published • loading... • Updated
FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy
The SAPIEN M3 system, backed by a 299-patient trial, achieved 95.7% near elimination of mitral regurgitation in patients unsuitable for surgery or repair.
Summary by Rutland Herald
10 Articles
10 Articles
Transseptal mitral valve replacement system approved
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.
Coverage Details
Total News Sources10
Leaning Left1Leaning Right0Center4Last UpdatedBias Distribution80% Center
Bias Distribution
- 80% of the sources are Center
80% Center
L 20%
C 80%
Factuality
To view factuality data please Upgrade to Premium




