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SynCardia Systems, Inc.

Press Release:

New York Times Posts Retro Report Documentary: The Total Artificial Heart - From 1st Implant to World’s Most Used Artificial Heart

Produced by Retro Report for The New York Times, this documentary traces the modern-day SynCardia Heart full circle from its origins as a permanent heart to successfully pioneering use as a bridge to transplant to a new FDA clinical study for permanent use.

Nalexia -Lexi- Henderson is the youngest person to go home without a human heart when, at 16, she was discharged from University of Florida Health Shands Children’s Hospital with the SynCardia Total Artificial Heart powered by the Freedom® portable driver. Nalexia “Lexi” Henderson is the youngest person to go home without a human heart when, at 16, she was discharged from University of Florida Health Shands Children’s Hospital with the SynCardia Total Artificial Heart powered by the Freedom® portable driver. TUCSON, Ariz. – March 21, 2016 – Learn the history and modern use of the SynCardia temporary Total Artificial Heart (TAH-t) from the world premiere 12-minute Retro Report documentary, "A Change of Heart," which re-examines this leading story of the past and brings you through to today’s news.

This documentary details the development of the SynCardia Total Artificial Heart and its direct predecessor, the Jarvik 7. Like a heart transplant, the TAH-t is the only approved device that eliminates end-stage biventricular (both sides) heart failure. This fatal condition results when the native heart’s two ventricles can no longer pump enough blood for a patient to survive.

Through personal stories of surgeons and SynCardia Total Artificial Heart patients, this documentary takes the audience from the first use of a Total Artificial Heart for permanent use in 1982 to today’s use as a bridge to a donor heart transplant.

“Use of SynCardia’s Total Artificial Heart Technology has gone full circle,” says Michael P. Garippa, SynCardia’s CEO and President. “The first implants were for permanent use. For the last 30 years the TAH-t has been used as a bridge to transplant. Now we are in an FDA Investigational Device Exemption (IDE) clinical study for 19 destination therapy patients who do not qualify for a donor heart transplant.”

“This study is generating data on the effective use of the SynCardia Heart as a way for patients to recover from heart failure and continue with a near-normal lifestyle without a human heart,” Garippa says. CAUTION: The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.

The SynCardia Total Artificial Heart is by far the most used artificial heart in the world. From 1969 through February 24, 2016 there have been 1,623 artificial implants representing 13 different designs. Of those implants, 1,576 used the SynCardia TAH-t or its direct predecessors. This represents 96% of all artificial heart implants and accounts for 98% (520 years) of patient support.

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About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is a medical technology company focused on developing and manufacturing the SynCardia temporary Total Artificial Heart (TAH-t). The SynCardia TAH-t is an implantable system designed to assume the full function of a failed human heart in patients suffering from end-stage biventricular (both sides) heart failure.

The SynCardia TAH-t is the only total artificial heart that is commercially available in the United States, European Union and Canada for use as a bridge to donor heart transplantation.

More than 1,560 implants of the SynCardia Total Artificial Heart account for over 520 patient years of life on the device. Since January 2012 more than 550 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart and received a successful donor heart transplant was nearly four years (1,473 days).

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital and live at home and in their communities. The Freedom® portable driver has been used by more than 235 patients, accounting for over 160 patient years of support.

About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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