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Syncardia heart gains two HUD designations.

Syncardia Systems Inc., a Tucson, Ariz-based cardiotech company, has won two HUD (humanitarian use device) designations from the U.S. Food and Drug Administration (FDA) for its new 50 cc Total Artificial Heart (TAH). The device is the only FDA-, Health Canada- and CE-approved-TAH, which is a device that replaces the two lower chambers of the heart, or the ventricles. The 50 cc device is a smaller version of the 70 cc Syncardia temporary-TAH, which received FDA approval as a bridge to transplant in 2004.

Similar to a heart transplant, the Syncardia TAH replaces both failing heart ventricles and the four heart valves, reportedly eliminating the symptoms and source of end-stage bi-ventricular failure. Unlike donor hearts, for which there are waiting lists, the TAH is immediately available at Syncardia certified centers. The device is designed to provide immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

"The 50 cc Total Artificial Heart is designed to fit patients of smaller stature, including many women and adolescents who are too small to receive the 70 cc Total Artificial Heart," said Michael Garippa, Syncardia chairman, CEO and president. "We are pleased the FDA recognized the needs of these underserved patient populations and was swift in approving the HUD designations. Together, the 70 cc and 50 cc Total Artificial Hearts will fit almost all adult men and women, and many adolescents, including patients with congenital conditions."

The first HUD designation granted to the device covers destination therapy. To be eligible, patients must be at risk of imminent death from non-reversible biventricular heart failure and not eligible for cardiac transplant. The second designation is as a pediatric bridge to transplant, so long as the child's body can accommodate the device.

A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for each indication of the 50 cc TAH.

Originally used as a permanent replacement heart, the SyncardiaTAH is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). According to the company, there have been more than 1,100 implants of the TAH, accounting for more than 300 patient years of life.

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Title Annotation:Top of the News
Publication:Medical Product Outsourcing
Date:Mar 1, 2013
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