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New Device Approval

Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) - P030011

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Syncardia temporary CardioWest™ Total Artificial Heart (TAH-t)
Applicant: SynCardia Systems, Inc.
Address: 1992 E. Silverlake Road, Tucson, AZ 85713
Approval Date: October 15, 2004
Approval Letter: http://www.fda.gov/cdrh/PDF3/P030011a.pdf

What is it? Syncardia temporary CardioWest™ Total Artificial Heart (TAH-t) is an implantable artificial heart intended to keep hospitalized patients alive while they are waiting for a heart transplant.

The temporary CardioWest™ TAH-t 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 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.

How does it work? The temporary CardioWest™ TAH-t is designed to duplicate the action of the natural heart ventricles.

• The two ventricles of the TAH-t are split into two parts by a diaphragm.
• Blood fills one side of each ventricle, and is ejected when a pulse of air pressure is applied to the opposite side of the diaphragm.
• Once set, a patient’s blood flow adjusts automatically as more blood fills each ventricle and is ejected
• This circulation by the TAH-t provides blood flow to both the lungs and the body.

When is it used? The temporary CardioWest™ TAH-t is used only in the hospital. The device is used as a "bridge to transplant" for patients waiting for a heart transplant who:

• have both sides of their heart failing (biventricular heart failure),
• do not respond to other treatments,
• are at imminent risk of death, and
• are waiting for a donor heart.

What will it accomplish? The temporary CardioWest™ TAH-t is used in patients to:

• provide circulatory support while waiting for a donor heart,
• restore kidney and liver function because normal blood flow is restored

In a clinical study, 79 percent of patients implanted with the temporary CardioWest™ TAH-t received a donor heart with an average mean time of device implantation of 79 days, demonstrating that the artificial heart could successfully serve as a bridge to transplant.

When should it not be used? The temporary CardioWest™ TAH-t should not be used in patients who:

• are not eligible for a heart transplant,
• do not fit the device,
• cannot be adequately anticoagulated, or
• have left sided heart failure only.

Additional information:
Summary of Safety and Effectiveness and labeling is available at: http://www.fda.gov/cdrh/PDF3/P030011b.pdf

Other:
FDA Talk Paper:
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01317.html

HeartHealth Online:
www.fda.gov/hearthealth

Manufacturer’s product website:
http://www.syncardia.com

November 3, 2004

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