New Humanitarian Device Approval

Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

DeBakey VAD® Child -

H030003

FDA approved this device under the Humanitarian Device Exemption (HDE) program . See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: DeBakey VAD® Child
Manufacturer: MicroMed Technology, Inc.
Address: 8965 Interchange Dr., Houston, TX 77054 USA
Approval Date: February 25, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/H030003a.pdf

What is it? The DeBakey VAD® Child is a miniaturized heart pump designed to help the left ventricle of the heart pump blood. It is intended for use in children 5 to 16 years old who are awaiting a heart transplant.

How does it work? The DeBakey VAD® Child uses electromagnetic energy to cause a single component to spin around its axis. The spinning motion of this component works to propel blood from the left ventricle of the heart into the ascending aorta and circulate it throughout the body.

When is it used? The DeBakey VAD® Child is a Humanitarian Use Device (HUD) intended for both home and hospital use in children who:

are between 5 and 16 years old, and
have end-stage left ventricular failure requiring temporary mechanical blood circulation until a heart transplant is performed.

What will it accomplish? Use of the DeBakey VAD® Child may allow children with severe left ventricular failure to survive long enough to receive a heart transplant.

When should it not be used? The DeBakey VAD® Child should not be used in children who:

are younger than 5 years old,
have right ventricular failure,
have a blood-clotting (primary coagulopathy) or platelet disorder such as hemophilia or Von Willebrand’s disease,
have a known allergy or sensitivity to the blood thinner Heparin, or
have anatomical anomalies that would prevent surgical connection of the outflow graft to the ascending aorta.

Additional information: SSPB and Labeling: http://www.fda.gov/cdrh/ode/H030003sum.html

Other:

An FDA Talk Paper on the DeBakey VAD® Child:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01280.html

American Heart Association information on left ventricular assist devices:
http://www.americanheart.org/presenter.jhtml?identifier=4599

Ventricular assist device information from the Cedars-Sinai Heart Center:
http://www.csmc.edu/2355.html

National Heart, Lung, and Blood Institute facts about heart transplants:
http://www.nhlbi.nih.gov/health/public/heart/other/hrt_lung.htm

Updated March 10, 2004

horizonal rule

Center for Devices and Radiological Health / CDRH