10 Implants of the Total Artificial Heart at University of Washington in 2012 Leads All SynCardia Certified Centers

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Seattle Hospital Sets New Record for Number of Implants Performed by a SynCardia Certified Center During Its First Year

SynCardia, UW Medicine, Total Artificial Heart, artificial heart, Freedom driver, Nahush Mokadam, Chris Marshall, heart failure, donor heart, heart transplant

Dr. Nahush A. Mokadam, the co-director of heart transplantation and director of mechanical circulatory support at University of Washington Medical Center, has performed a record 10 implants of the SynCardia Total Artificial Heart in 2012. Photo by Clare McLean/UW Medicine

The availability of the portable driver has given our patients the opportunity to be discharged while awaiting transplantation. This is a great advance for our program. We look forward to when the smaller devices under development become available.

SynCardia Systems, Inc. (http://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.

"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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that provides 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.

SynCardia Wins Two Gold Stevies® at 2012 American Business Awards

On June 18, 2012, SynCardia was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won "Company of the Year – Health Products and Services" and "Most Innovative Company of the Year – up to 100 Employees." See the full list of SynCardia Awards & Recognition, which includes accolades from Forbes, Fast Company and more.

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Don Isaacs
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