Share “FDA OKs HeartWare device for transplant...”

FDA OKs HeartWare device for transplant patients

Associated Press Modified: November 20, 2012 at 2:15 pm •  Published: November 20, 2012

WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a new heart pump for patients with severe heart failure who are awaiting a heart transplant.

Regulators approved HeartWare's Ventricular Assist System, a battery-powered device that is implanted in the chest, where it helps the heart's lower left chamber pump blood throughout the body.

The FDA has previously approved similar devices, known as ventricular assist devices, but HeartWare's device is smaller and may be easier to implant in some patients.

FDA says the approval was based on a company study of 137 advanced heart failure patients implanted with the device. Study results showed rates of adverse events, including infection and stroke, were similar to those seen with older devices.

Medical device maker HeartWare International Inc. is based in Framingham, Mass.


  1. 1
    Report: Williams Cos. investors file class action suit over ETE sale
  2. 2
    Undercover investigation into Tulsa house believed to be site of prostitution, drugs leads to two...
  3. 3
    Pioneer Woman Ree Drummond juggles new cookbook, cookware, show
  4. 4
    Oklahoma 8th-grader hit in crosswalk
  5. 5
    Student sent home from Edmond school after discovery of 'hit list'
+ show more


× Trending business Article