Edwards Lifesciences Corp

Edwards Lifesciences Corp(EW)のニュースとイベント

$88.290

+1.086 (+1.23%)終値時点

EW のニュース

EW のイベント

10/21 09:30

Edwards Lifesciences Receives FDA Approval for PASCAL System

Edwards Lifesciences announced that the U.S. Food and Drug Administration, FDA, has approved its PASCAL Precision system for tricuspid valve repair. The system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy who are deemed at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair, T-TEER, by a multidisciplinary heart team.

10/1 16:30

Edwards Lifesciences Receives FDA Approval for AUTUS Size-Adjustable Valve

Edwards Lifesciences "announced that the U.S. Food and Drug Administration has approved the AUTUS Size-Adjustable Valve, a surgical pulmonary valve designed specifically for pediatric patients with congenital heart disease who require pulmonary valve replacement. For many pediatric patients, pulmonary valve replacement is not a one-time event. The AUTUS valve is the first FDA-approved surgical pulmonary valve designed for pediatric anatomy, with the ability to be expanded as a child grows. Valve expansion is performed through a minimally invasive transcatheter procedure, potentially reducing the need for repeat open-heart surgeries."

9/10 18:00

Edwards Lifesciences Welcomes NCD for TAVR

Edwards Lifesciences issued a statement in response to the national coverage determination, or NCD, for transcatheter aortic valve replacement, or TAVR, released by the Centers for Medicare & Medicaid Services. Highlights of the statement follow: "Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary Heart Team...The modernized policy recognizes the importance of timely care by supporting a more streamlined patient care journey and giving Heart Teams greater flexibility to apply their expertise to both patient evaluation and treatment based on each patient's clinical needs...As implementation and adoption of the NCD are expected to take time, the company has confidence in its previously communicated financial guidance for 2026. Edwards will provide 2027 and longer-term guidance at its investor conference in December. As always, Edwards remains committed to working with stakeholders to support thoughtful implementation of the NCD and timely access and high-quality TAVR care for patients in need".

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