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 ...
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 ...
MedTech Dive

CMS proposes Medicare coverage expansion for TAVR

The proposed Medicare coverage change could help Edwards Lifesciences gain market share from Medtronic and Boston Scientific, ...
Nasdaq

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 ...
Orange County Business Journal

FDA Panel OK’s Edwards Sapien Heart Valve

A Food and Drug Administration advisory panel on Wednesday cleared a replacement heart valve made by Irvine-based Edwards Lifesciences Corp. for patients too sick to have open-heart surgery. Edwards ...
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 ...
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 ...
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 ...
MD&M East

Did Edwards’ Sapien Platform Have Positive Long-Term Results?

Edwards Lifesciences might be a pioneer in the transcatheter aortic valve replacement market, but that doesn’t mean it’s smooth sailing in the space. The Irvine, CA-based company faces stiff ...
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' ...