Federal regulators on Tuesday approved for sale in the United States a mechanical pump built by a Framingham company as a “bridge therapy” to support heart function and blood flow in patients with end-stage heart failure who are awaiting a heart transplant.
The device cleared by the Food and Drug Administration, called the HeartWare Ventricular Assist System, was developed by Heart Ware International Inc. Designed for use inside or outside the hospital, it includes an implantable pump with an external driver and power source. The device has been on the market in Europe since 2009 and in Australia since last year.
“For patients awaiting a donor heart, the HeartWare System provides a new treatment option,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.