2014

1,200th Worldwide Implant of the SynCardia Total Artificial Heart Occurs in Indiana Patrick O'Hara Also is the 1st Indianan to be Implanted with the SynCardia Heart and the 1st Discharged From the Hospital Without a Human Heart, Thanks to the Freedom® Portable Driver

TUCSON, Ariz., Nov. 12, 2013 /PRNewswire/ -- An Indiana man has become the 1,200th person in the world to be implanted with the SynCardia temporary Total Artificial Heart. Patrick O'Hara is the first person in Indiana to receive the life-saving device and the first Hoosier to be discharged from the hospital with the Freedom® portable driver.

(Photo: http://photos.prnewswire.com/prnh/20131112/LA14803)

On June 26, 2013, O'Hara, 59, received the SynCardia Total Artificial Heart at Indiana University Health Methodist Hospital as a bridge to transplant. It's the only device that eliminates the source and symptoms of biventricular (both sides) heart failure. Dr. I-wen Wang, M.D., Ph.D., an IU Health cardiothoracic surgeon who specializes in heart and lung transplantation and ventricular-assist devices, implanted the SynCardia Heart when O'Hara's own organ, weakened by 30 years of heart disease, began to fail.

"Mr. O'Hara went from having blue fingertips from lack of sufficient blood flow to walking out of the hospital on his own power," says Dr. Wang. "The SynCardia Total Artificial Heart has given him a chance to get stronger in preparation for his heart transplant."

O'Hara left IU Health Methodist Hospital on October 10 carrying the 13.5-pound wearable Freedom driver in the backpack. Powered by two lithium batteries, the driver provides precisely calibrated pulses of air to operate the SynCardia Heart.

The Freedom portable driver allows patients to be discharged to their home and community to wait for a donor heart. Almost all of what would have been O'Hara's in-hospital costs have been eliminated for this portion of his care. O'Hara is undergoing outpatient cardiac rehabilitation to regain his strength. He's also looking forward to fishing and eating out at restaurants.

"It's mind-blowing how technology has advanced to create new possibilities for patients with end-stage heart disease," says Dr. Wang. "Heart devices have evolved for the benefit of all patients."

SynCardia Systems Inc. manufactures the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. Like a donor heart, the SynCardia Heart replaces both failing heart ventricles and the four heart valves.

Originally used as a permanent replacement heart, the SynCardia Heart currently is approved as a bridge to transplant. A 10-year pivotal clinical study showed that the SynCardia Total Artificial Heart had a 79% bridge to transplant rate, which is the highest transplant rate for any approved heart device in the world.

O'Hara's June 26 surgery marked the 1,200th time the SynCardia Total Artificial Heart has been implanted. Since then the number of implants have reached nearly 1,250, accounting for more than 335 patient years of life on the device. So far this year more than 135 SynCardia Hearts have been implanted, more than in all of 2012.

IU Health Methodist Hospital is among 93 SynCardia Certified Centers worldwide. Another 35 medical centers are in the process of certification.

"Surgeons around the world are finding more reasons to implant the SynCardia Total Artificial Heart to help end-stage biventricular heart failure patients," says Michael P. Garippa, CEO and president of SynCardia Systems.

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.

Read IU Health's press release and watch video about Patrick O'Hara.

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, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,200 implants of the Total Artificial Heart, accounting for more than 335 patient years of life on the device.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 93 SynCardia Certified Centers worldwide with 35 others in the process of certification.

The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Forbes Ranks SynCardia #69 Among "America's Most Promising Companies"

In its February 2013 issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. See the full list of SynCardia Awards & Recognition.

For additional information, please visit: http://www.syncardia.com
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SOURCE SynCardia Systems, Inc.



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