Featured Research

from universities, journals, and other organizations

FDA Approves Heart Assist Device For Children

Date:
March 1, 2004
Source:
U.S. Food And Drug Administration
Summary:
The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for a miniaturized heart pump for children aged 5 to 16 who are awaiting a heart transplant.

February 26, 2004 -- The U.S. Food and Drug Administration today approved a Humanitarian Device Exemption (HDE) for a miniaturized heart pump for children aged 5 to 16 who are awaiting a heart transplant.

The product, called a ventricular assist device, is designed to help the left ventricle of the heart pump blood. Use of the device may allow children with severe left ventricle failure to survive long enough to receive a heart transplant.

The product is the DeBakey VAD Child, manufactured by MicroMed Technology, Inc., of Houston. While similar devices have been approved for use in adults, this is the first one to be approved for use in children.

An HDE is a special regulatory marketing approval that makes devices available on a limited basis for patients with rare medical conditions—those that affect fewer than 4,000 people annually in the United States. It is estimated that fewer than 100 children a year will be candidates for the new device.

FDA approved the HDE based on a review of data from 190 adults worldwide who were implanted with this device, and on extensive mechanical testing performed by MicroMed.

The data shows that the miniaturized device has a reasonable probability of being safe and effective in children. Without such a device, many children with severe left ventricle heart failure would die before a heart became available for transplant.


Story Source:

The above story is based on materials provided by U.S. Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food And Drug Administration. "FDA Approves Heart Assist Device For Children." ScienceDaily. ScienceDaily, 1 March 2004. <www.sciencedaily.com/releases/2004/02/040229233839.htm>.
U.S. Food And Drug Administration. (2004, March 1). FDA Approves Heart Assist Device For Children. ScienceDaily. Retrieved July 30, 2014 from www.sciencedaily.com/releases/2004/02/040229233839.htm
U.S. Food And Drug Administration. "FDA Approves Heart Assist Device For Children." ScienceDaily. www.sciencedaily.com/releases/2004/02/040229233839.htm (accessed July 30, 2014).

Share This




More Health & Medicine News

Wednesday, July 30, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Generics Eat Into Pfizer's Sales

Generics Eat Into Pfizer's Sales

Reuters - Business Video Online (July 29, 2014) Pfizer, the world's largest drug maker, cut full-year revenue forecasts because generics could cut into sales of its anti-arthritis drug, Celebrex. Fred Katayama reports. Video provided by Reuters
Powered by NewsLook.com
Nigeria Ups Ebola Stakes on 1st Death

Nigeria Ups Ebola Stakes on 1st Death

Reuters - Business Video Online (July 29, 2014) Nigerian authorities have shut and quarantined a Lagos hospital where a Liberian man died of the Ebola virus, the first recorded case of the highly-infectious disease in Africa's most populous economy. David Pollard reports Video provided by Reuters
Powered by NewsLook.com
Running 5 Minutes A Day Might Add Years To Your Life

Running 5 Minutes A Day Might Add Years To Your Life

Newsy (July 29, 2014) According to a new study, just five minutes of running or jogging a day could add years to your life. Video provided by Newsy
Powered by NewsLook.com
Ebola Outbreak Poses Little Threat To U.S.: CDC

Ebola Outbreak Poses Little Threat To U.S.: CDC

Newsy (July 29, 2014) The Ebola outbreak in West Africa poses little threat to Americans, according to officials with the Centers for Disease Control and Prevention. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins