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Medical Devices / Submissions and Approvals

V-Wave’s Heart Failure Shunt Snags Breakthrough Designation

Aug. 16, 2019

V-Wave has earned breakthrough device status from the FDA for its interatrial shunt implant for chronic heart failure.

The minimally invasive, miniature shunt is implanted in patients to help control left atrial pressure, which causes heart failure symptoms to worsen and accounts for over three million hospitalizations per year, the Israeli devicemaker said.

The shunt is designed to relieve symptoms, reduce hospitalization, increase exercise tolerance and improve patients’ quality of life.

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