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Home » Edwards Lifesciences Warns Doctors About Valve System

Edwards Lifesciences Warns Doctors About Valve System

July 18, 2019

Edwards Lifesciences warned users about the risk of balloon breakage when withdrawing the Sapien 3 Ultra transcatheter heart valve system from the patient.

The device is used for severe, symptomatic aortic stenosis patients at intermediate or higher risk of requiring open-heart surgery. The company said that bursting balloons accounted for approximately one percent of complaints.

Edwards has expanded the device’s instructions for use to include a warning about failing to inflate the device slowly. It is also updating the training materials with a new method for retrieving a burst balloon through the sheath.

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