SynCardia Setting a Record Breaking Pace in 2013

The SynCardia Total Artificial Heart has been implanted 125 times this year, surpassing the 125 SynCardia hearts implanted in all of 2012. The Freedom® portable driver is the world’s first wearable power supply for the SynCardia Total Artificial Heart.

TUCSON, Ariz. – Sept. 24, 2013 – On Sept. 24, 2013, the 125th implant of the SynCardia temporary Total Artificial Heart was performed. This number equals all implants performed worldwide in 2012 and a 244% increase over 2011. SynCardia Systems, Inc. projects concluding 2013 with another new record – 180 Total Artificial Heart implants in one year, the company announced today.

Like a donor heart transplant, a SynCardia Total Artificial Heart replaces the two dying ventricles (that pump the blood) and four heart valves. It is the only device that eliminates the symptoms and source of end stage heart failure. For many heart surgeons it has become the standard of care for patients dying of heart failure affecting both sides of the heart (biventricular failure).

“In the sickest patients, especially when RV failure is present, we have found the SynCardia Total Artificial Heart to be the device of choice,” said Dr. Jack Copeland, professor of surgery at the University of California San Diego Health System. “It provides the patient with immediate, safe blood flow of 7 to 9.5 liters per minute through each ventricle using the shortest blood path of any mechanical circulatory support device. The right ventricle of the Total Artificial Heart helps reduce central venous pressure, which helps recover vital organs such as the kidney and liver.”

U.S. News & World Report’s 2013-2014 hospital rankings of the 50 best cardiology and heart surgery medical centers includes 27 that are certified centers or are in the process of becoming certified. That’s 54%, including four of the top five. Certified center surgeons are advancing the use of Total Artificial Heart to fit the needs of their patient populations.

“The Total Artificial Heart has opened the flood gates in respect to the treatment possibilities for a quickly growing population of children in heart failure, including adolescents suffering from chronic rejection of their transplanted heart, end-stage heart failure accompanied by multiple congenital defects and a late-stage failing Fontan circulation,” said David Morales, MD, chief of Pediatric Cardiothoracic Surgery, Cincinnati Children’s Hospital Medical Center.

“SynCardia’s Freedom® Portable Driver allows stable patients to be discharged from the hospital to wait for a matching donor heart at home and in their communities, said Michael P. Garippa, SynCardia’s CEO and president. “When patients are home, they are happier. They are sleeping in their own beds, exercising, eating out and socializing and some even return to work. They are getting their bodies in better shape for living life and their transplant.”

The Freedom® Portable Driver, the world’s first wearable power supply for the SynCardia Total Artificial Heart, provides precisely calibrated pulses of air to move the blood-pumping diaphragms within the heart. The driver, carried in a backpack or shoulder bag, has supported more than 145 patients for the equivalent of over 75 patient years.

Another reason for rapid growth in the use of the SynCardia Total Artificial Heart is expanding availability. “Our implant capacity has grown 300 percent due to the Companion 2 Hospital driver. The Freedom portable driver makes mobilization and discharge of stable Total Artificial Heart patients a reality,” Garippa said. “In the U.S. where we are in an FDA-approved Investigational Device Exemption (IDE) clinical study, 81 patients have been supported by the Freedom driver with 58 being discharged from the hospital.”

Unlike a donor heart, the SynCardia Total Artificial Heart is immediately available at a growing number of SynCardia Certified Centers. Today there are 87 such centers worldwide with an additional 33 heart centers currently pursuing certification. Overall, surgeons have implanted more than 1,200 SynCardia Total Artificial Hearts worldwide, accounting for more than 335 patient years of life on the device.

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.

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