|By PR Newswire||
|December 6, 2012 09:35 AM EST||
TUCSON, Ariz., Dec. 6, 2012 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that University of Washington (UW) Medical Center in Seattle has performed 10 implants of the SynCardia temporary Total Artificial Heart so far in 2012, the most of any SynCardia Certified Center this year. It also marks a new record for number of implants performed by a hospital during its first year as a SynCardia Certified Center.
Watch video of Dr. Mokadam discussing the Total Artificial Heart and patient Chris Marshall - http://www.syncardia.com/Educational/uw-medicine-patient-gets-total-artificial-heart-and-patient-chris-marshall.html
"We utilize this device to support patients in whom left ventricular assist device (LVAD) support would be ineffective or contraindicated," said Dr. Nahush A. Mokadam, the co-director of heart transplantation and director of mechanical circulatory support at UW Medical Center. "We have implanted patients with biventricular failure with refractory ventricular tachycardia, restrictive cardiomyopathy, giant cell myocarditis, post-infarct ventricular septal defect, multiple LVAD thromboses and unreconstructable aortomitral endocarditis to name a few, and they have benefitted greatly from this technology."
In January, UW Medical Center performed its first two implants of the SynCardia Total Artificial Heart during a three-day span. In March, UW became the first hospital in the Pacific Northwest to discharge a SynCardia Total Artificial Heart patient using the Freedom® portable driver. The patient, avid hiker Chris Marshall, logged more than 600 miles while he waited for his donor heart. On Sept. 12, he was successfully bridged to a heart transplant after 219 days of support. Currently, UW has four Total Artificial Heart patients waiting for a matching donor heart.
"The availability of the portable driver has given our patients the opportunity to be discharged while awaiting transplantation," said Dr. Mokadam. "This is a great advance for our program. We look forward to when the smaller devices under development become available. It will allow this lifesaving technology to be offered to a wider patient population that is currently being undertreated."
The current 70cc Total Artificial Heart fits a majority of men and some women. It is designed for use in patients with a Body Surface Area (BSA) of 1.7m² or greater. SynCardia is currently developing a smaller 50cc Total Artificial Heart designed for patients with a BSA of 1.2-1.7m².
There are currently 74 SynCardia Certified Centers worldwide, including 39 in the U.S. There are an additional 30 hospitals currently undergoing SynCardia's four-phase certification process.
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 portable driver is an investigational device, limited by United States law to investigational use.
The 50cc Total Artificial Heart is not for Human Use. This product is in the research and development phase and will not be available for sale in the United States or Europe until all regulatory requirements have been met.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart… read more
SOURCE SynCardia Systems, Inc.
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