Featured Research

from universities, journals, and other organizations

FDA Approves Temporary Artificial Heart

Date:
October 19, 2004
Source:
U.S. Food And Drug Administration
Summary:
The Food and Drug Administration (FDA) has approved a partial artificial heart intended to keep people alive in the hospital while they are awaiting a heart transplant.

SynCardia CardioWest(TM) Temporary Total Artificial Heart (TAH-t) is the first ever FDA-approved temporary total artificial heart.
Credit: Photo : Business Wire

The Food and Drug Administration (FDA) has approved a partial artificial heart intended to keep people alive in the hospital while they are awaiting a heart transplant.

Related Articles


The product is a pulsating bi-ventricular device that is implanted into the chest to replace the patient's left and right ventricles (the bottom half of the heart). The implanted device is sewn to the patient's remaining atria (the top half of the heart). Hospitalized patients are connected by tubes from the heart through their chest wall to a large power-generating console, which operates and monitors the device.

The heart is manufactured by Syncardia Systems Inc., of Tucson, Ariz. It is intended as a "bridge to transplant" for people waiting for a heart transplant who do not respond to other treatments and are at risk of imminent death from non-reversible bi-ventricular failure, i.e. people with both left and right side heart failure, and who are eligible for a heart transplant.

FDA approved the Syncardia device based on a review of clinical studies of safety and effectiveness conducted by the firm and on the recommendation of an outside panel of experts convened by FDA to review the device.

The firm studied use of the artificial heart in 81 transplant-eligible patients with severe bi-ventricular heart failure at five medical centers in the United States. In the studies, 79 percent of patients implanted with the heart remained alive long enough to receive a donor heart (an average of 79 days), demonstrating that the artificial heart could successfully serve as a bridge to transplant.

Complications included infection (72% of patients), bleeding (42%), neurological event such as major or minor stroke (25%) and device malfunctions (18%). Seventeen patients in the study died before a donor heart became available.

About 4,000 patients in the United States await heart transplants annually. Only about 2,200 donor hearts typically become available. About 100 of the 4,000 patients awaiting transplants have non-reversible bi-ventricular failure and could be candidates for the new artificial heart.

FDA is requiring the firm to conduct a post-approval study to monitor the device's performance in commercial use.


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 Temporary Artificial Heart." ScienceDaily. ScienceDaily, 19 October 2004. <www.sciencedaily.com/releases/2004/10/041019085051.htm>.
U.S. Food And Drug Administration. (2004, October 19). FDA Approves Temporary Artificial Heart. ScienceDaily. Retrieved December 18, 2014 from www.sciencedaily.com/releases/2004/10/041019085051.htm
U.S. Food And Drug Administration. "FDA Approves Temporary Artificial Heart." ScienceDaily. www.sciencedaily.com/releases/2004/10/041019085051.htm (accessed December 18, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Thursday, December 18, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

UN: Up to One Million Facing Hunger in Ebola-Hit Countries

UN: Up to One Million Facing Hunger in Ebola-Hit Countries

AFP (Dec. 17, 2014) Border closures, quarantines and crop losses in West African nations battling the Ebola virus could lead to as many as one million people going hungry, UN food agencies said on Wednesday. Duration: 00:52 Video provided by AFP
Powered by NewsLook.com
When You Lose Weight, This Is Where The Fat Goes

When You Lose Weight, This Is Where The Fat Goes

Newsy (Dec. 17, 2014) Can fat disappear into thin air? New research finds that during weight loss, over 80 percent of a person's fat molecules escape through the lungs. Video provided by Newsy
Powered by NewsLook.com
Why Your Boss Should Let You Sleep In

Why Your Boss Should Let You Sleep In

Newsy (Dec. 17, 2014) According to research out of the University of Pennsylvania, waking up for work is the biggest factor that causes Americans to lose sleep. Video provided by Newsy
Powered by NewsLook.com
Flu Outbreak Closing Schools in Ohio

Flu Outbreak Closing Schools in Ohio

AP (Dec. 17, 2014) A wave of flu illnesses has forced some Ohio schools to shut down over the past week. State officials confirmed one pediatric flu-related death, a 15-year-old girl in southern Ohio. (Dec. 17) Video provided by AP
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:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

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