The US FDA has issued an early alert for some Commander M delivery systems used with Edwards Lifesciences’ Sapien M3 ...

A new FDA-approved pulmonary valve should reduce the number of open-heart surgeries children with congenital heart disease ...

The U.S. Food and Drug Administration (FDA) issued a high-risk early alert after Edwards Lifesciences Corp. EW recalled ...

Edwards is asking customers to return some of the delivery systems used with its Sapien M3 devices after receiving three ...

Edwards Lifesciences has received multiple reports of the delivery systems malfunctioning in a way that puts patient at risk.

Edwards said it received three reports of delivery balloons bursting during procedures to implant its Sapien M3 transcatheter ...

Robotic cardiac (heart) surgery is a minimally invasive alternative to traditional open-heart procedures but requires specialized expertise.

An issue with the delivery component of Edwards’ SAPIEN M3 TMVR system has been associated with one patient death and one ...

When replacing the aortic valve, a small aortic root can limit the size of the prosthetic valve that can be implanted.

The US FDA warns of serious risks related to Edwards Lifesciences' heart valve delivery systems following reports of balloon ...

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