MassDevice

Edwards has 10-year data supporting durability of Resilia tissue for heart valve tech

Edwards Lifesciences (NYSE:EW) today announced 10-year results from the COMMENCE aortic trial supporting its proprietary ...
Seeking Alpha

FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

IRVINE, Calif.--(BUSINESS WIRE)-- Edwards Lifesciences (EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach ...
Business Wire

Edwards SAPIEN M3 Receives CE Mark, Becoming World’s First Transfemoral Transcatheter Mitral Valve Replacement System

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system received CE Mark for the transcatheter treatment of ...
Nasdaq

Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System Wins FDA Approval

(RTTNews) - Edwards Lifesciences Corp. (EW) on Tuesday said its SAPIEN M3 mitral valve replacement system received U.S. Food and Drug Administration (FDA) approval for the treatment of mitral ...
Reuters

Edwards says new heart valve data encouraging

(Reuters) - Edwards LifeSciences Corp on Monday said patients who received the company's Sapien replacement heart valve through an incision between the ribs fared better in a new study than an earlier ...
Orange County Business Journal

FDA Clears New Indication for Edwards’ Sapien 3

Edwards Lifesciences Corp.’s Sapien 3 platform has been approved for a new indication. The Food and Drug Administration recently cleared the line of catheter-based heart valves, which includes Sapien ...
Reuters

Edwards heart valve improves quality of life: study

CHICAGO (Reuters) - Edwards LifeSciences Corp's less-invasive replacement heart valve alleviates symptoms such as fatigue and breathlessness better than standard medical therapy, data released on ...
Business Wire

Edwards’ SAPIEN 3 Ultra RESILIA Valve Demonstrates Continued Excellent Outcomes for Patients in Real World Data

LONDON--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced one-year data highlighting the continued outstanding performance of its SAPIEN 3 Ultra RESILIA valve. The data were presented ...
RAPS

FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high ...
The Washington Post

Artificial Sapien heart valve sparks safety questions as wider use is considered

Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, in advance of a meeting Wednesday to consider broadening its ...
Orange County Business Journal

Edwards Profit Edges Up; Shares Fall on Sapien Concerns

Irvine-based Edwards Lifesciences Corp. on Thursday posted a slightly higher second-quarter profit as growing sales of its heart valves offset higher costs. Edwards also offered a conservative outlook ...