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 ...
Orange County Business Journal

Edwards: Heart Valve Effective for High-Risk Patients

Edwards Lifesciences Corp. of Irvine said Monday that nearly two-thirds of high-risk patients who received its less-invasive heart valve remained alive two years after treatment. Edwards, a maker 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 ...
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 ...
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 ...
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 ...
FierceBiotech

Edwards nets mitral valve replacement approval in Europe

After acquiring its developer last year, Edwards Lifesciences has now obtained a European approval for what it described as the world’s first transfemoral transcatheter mitral valve replacement ...
Washington Examiner

FDA reviews safety of innovative heart valve

WASHINGTON (AP) — Federal health officials are asking safety questions about the first artificial heart valve designed to be implanted without major surgery, ahead of a meeting this week to consider ...
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 ...
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 ...