Home : Health : Heart Health :

Heart Health

Study: how sharply should we cut salt?

Make no mistake: Most Americans eat way too much, not just from…

Keeping organs 'alive' outside the body

Placing healthy organs in the same container we use to keep …

Heart attacks: What you should know

Immediate medical attention is crucial if you are having a …

Finding fitness that works for you

Researching a health topic can lead to confusion, frustration …

Antibiotic can cause fatal heart rhythm

A study found a 2.5 times higher risk of death in the first …

FDA OKs HeartWare device for transplant patients

New pump for those with severe heart failure

Updated: Tuesday, 20 Nov 2012, 4:19 PM EST
Published : Tuesday, 20 Nov 2012, 4:19 PM EST

The Associated Press

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.

Comments

With WIVB.com's new commenting system you don't need to register. You can login with an existing Facebook, Yahoo!, Google, or Twitter account and more. If you have a WIVB.com login you can still use it in our Participate section.