You can now read 5 articles in a month for free on BostonGlobe.com. Read as much as you want anywhere and anytime for just 99¢.

Around the Region

Pre-transplant heart device is OK’d

Continue reading below

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.

Robert Weisman can be reached at weisman@globe.com.
Loading comments...
Subscriber Log In

We hope you've enjoyed your 5 free articles'

Stay informed with unlimited access to Boston’s trusted news source.

  • High-quality journalism from the region’s largest newsroom
  • Convenient access across all of your devices
  • Today’s Headlines daily newsletter
  • Subscriber-only access to exclusive offers, events, contests, eBooks, and more
  • Less than 25¢ a week
Marketing image of BostonGlobe.com
Marketing image of BostonGlobe.com
Already a subscriber?
Your city. Your stories. Your Globe.
Yours FREE for two weeks.
Enjoy free unlimited access to Globe.com for the next two weeks.
Limited time only - No credit card required!
BostonGlobe.com complimentary digital access has been provided to you, without a subscription, for free starting today and ending in 14 days. After the free trial period, your free BostonGlobe.com digital access will stop immediately unless you sign up for BostonGlobe.com digital subscription. Current print and digital subscribers are not eligible for the free trial.
Thanks & Welcome to Globe.com
You now have unlimited access for the next two weeks.
BostonGlobe.com complimentary digital access has been provided to you, without a subscription, for free starting today and ending in 14 days. After the free trial period, your free BostonGlobe.com digital access will stop immediately unless you sign up for BostonGlobe.com digital subscription. Current print and digital subscribers are not eligible for the free trial.