FDA approves heartware device for transplant patients awaiting organs | Redux

FDA approves heartware device for transplant patients awaiting organs

FDA Intends to Remove Unapproved Drugs from Market by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work

Excerpt:

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.

Keywords:

heart failure ventricular assist devices heart transplant new heart Medical device pump adverse events the heart battery-powered Framingham infection Drug stroke maker Mass rates results International

FDA approves heartware device for transplant patients awaiting organs

Additional Info:

HealthCondition: heart failure

Overall Sentiment: 0.122919

Relevance: 0.888205

Disambiguation: DiseaseOrMedicalCondition | CauseOfDeath | DiseaseCause | Symptom | DiseaseReferences:

• Heart failure: dbpedia
• Heart failure: freebase

FieldTerminology: Medical device maker

Overall Sentiment: 0

Relevance: 0.528854

Organization: Food and Drug Administration

Overall Sentiment: 0.329553

Relevance: 0.643622

Disambiguation: References:

• U.S. Food and Drug Administration: dbpedia
• U.S. Food and Drug Administration: opencyc

Company: HeartWare

Overall Sentiment: 0.251596

Relevance: 0.427261

URL Meta Tags Details

Source Webpage: FDA approves heartware device for transplant patients awaiting organs

URL Provided Title:

FDA approves heartware device for transplant patients awaiting organs

URL Provided Keywords:

• Drug Administration
• Food and Drug Administration
• Framingham
• heart
• heart failure
• heartware international
• medical device
• Stroke
• study
• ventricular assist system

URL Provided Desc:

The Food and Drug Administration on Tuesday approved a new heart pump for patients with severe heart failure who are awaiting a heart transplant

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