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Video Length - 2:30

FDA Could Approve
New Heart Transplant Technology

CBS Houston

May 15, 2012 - The FDA could fully approve a heart device for use without a transplant in weeks.

SynCardia’s Total Artificial Heart is a pump implanted in place of the heart, powered by a backpack-sized driver so the patient is able to leave the hospital and lead a nearly normal life.

“I would not be here today without the device,” said Shawn Galloway, a Total Artificial Heart recipient. “People die every single day because they don’t get an organ in time.”

News Update:
On March 2, the U.S. Food and Drug Administration (FDA) approved a Humanitarian Use Device (HUD) designation for the Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant. The next step is for SynCardia to submit a Humanitarian Device Exemption (HDE) to the FDA. Once approved, the HDE will allow up to 4,000 U.S. patients annually who are not transplant-eligible to receive the Total Artificial Heart on a permanent basis.

*The Freedom® portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. CAUTION – The Freedom driver is an investigational device, limited by United States law to investigational use.

 
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