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New Humanitarian Device Approval

Heartsbreath - H030004

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: Heartsbreath
Manufacturer: Menssana Research, Inc.
Address: 1 Horizon Road, Suite 1415, Fort Lee, NJ 07024-6510
Approval Date: February 24, 2004
Approval Letter: http://www.fda.gov/cdrh/ode/H030004sum.html

What is it? The Heartsbreath test is a breath test that is used along with a traditional heart (endomyocardial) biopsy on patients who have received a heart transplant within the past year. This test measures possible organ rejection in heart transplant patients.

How does it work? The Heartsbreath test works by measuring the amount of methylated alkanes (natural chemicals found in the breath and air) in a patient’s breath.

• The patient breathes into a plastic mouth piece that is attached to a breath collecting device.
• The device subtracts the amount of methylated alkanes in a patient’s breath from the amount of methylated alkanes in the room air.
• The value generated by the device is compared to the results of a biopsy performed during the previous month to measure the probability of the implanted heart being rejected.

When is it used? The Heartsbreath test may be used in patients who have had heart transplants within the past year. The results of the Heartsbreath test should be compared to a heart biopsy performed during the previous month.

What will it accomplish? The Heartsbreath test may be used along with the results of a heart biopsy to help guide short term and long term medical care of heart transplant patients.

The test’s greatest value may be in helping to separate less severe organ rejection (grades 0, 1, and 2) from more severe rejection (grade 3).

When should it not be used? The Heartsbreath test should not be used for patients who:

• have received a heart transplant more than one year ago, or
• have a grade 4 heart transplant rejection because Heartsbreath has not been evaluated in these patients.

Additional information:

SSPB and Labeling: http://www.fda.gov/cdrh/ode/H030004sum.html

Illustrated anatomy of the heart:
http://www.tmc.edu/thi/anatomy2.html

Fact sheet for heart transplant patients from the American Heart Association:
http://circ.ahajournals.org/cgi/reprint/106/14/1750.pdf

Updated March 10, 2004

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