TCTMD

Edwards SAPIEN XT Transcatheter Valve Continues to Achieve Positive Patient Outcomes in 94 Center Post-Approval Study

Company Receives CE Mark Approval for 29 mm Transfemoral System First Human Experience With Next-Generation Valve Platforms to Be Presented PARIS-- Edwards Lifesciences Corporation, the global leader ...
Orange County Business Journal

Edwards Comeback Continues on OK for Sapien XT

Edwards Lifesciences Corp.’s next generation of less-invasive heart valves is making its domestic debut, providing a boost that has extended a monthslong rally for shares of the Irvine-based heart ...
TCTMD

Edwards' SAPIEN XT Valve Approved in Europe for Transcatheter Mitral and Aortic Valve-in-Valve Procedures

IRVINE, CA. -- Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark in Europe for valve-in-valve ...
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 Ready to Roll on Sapien Sales

Irvine-based Edwards Lifesciences Corp. is wasting no time getting its recently approved heart valve on the market here. Edwards Sapien is a less-invasive device that’s widely considered one of the ...
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 ...
FierceBiotech

Edwards' next-gen Sapien heart valve gains Japanese reimbursement

Japan granted an insurance reimbursement for the Sapien XT valve.--Courtesy of Edwards Lifesciences Edwards Lifesciences' ($EW) Sapien heart-valve revenue engine gets ...
Nasdaq

Edwards Gets FDA Approval For SAPIEN 3 With Alterra For Transcatheter Pulmonic Valve Replacement

(RTTNews) - Edwards Lifesciences (EW) said it received approval from the U.S. Food and Drug Administration for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent ...
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 ...
MD&M East

Edwards to Launch Sapien 3 In Europe

Edwards Lifesciences has received regulatory approval to sell its third-generation Sapien 3 transcatheter aortic heart valve in Europe. The news comes shortly after its rival Medtronic ended Edwards' ...
FierceBiotech

Edwards hit with shareholder suit over 'misleading' Sapien claims

Stockholders are accusing Edwards Lifesciences of misleading the public about sales of its Sapien valve.--Courtesy of Edwards Lifesciences Salty investors are taking ...