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SynCardia Systems, Inc.

Press Release:

World’s Leading Artificial Heart Center, La Pitié Hospital, Paris, Celebrates 30 Years and 249 Implants of the SynCardia Total Artificial Heart

In 1986, under the pioneering leadership of Prof. Christian Cabrol, La Pitié performed the first Total Artificial Heart implantation in France and has implanted more SynCardia Total Artificial Hearts than any other medical center in the world.

La Pitié accounts for 16% of the 1,586 SynCardia temporary Total Artificial Heart (TAH-t) implants and those of its direct predecessors. France is responsible for 357, or 23% of all TAH-t implants worldwide. La Pitié accounts for 16% of the 1,586 SynCardia temporary Total Artificial Heart (TAH-t) implants and those of its direct predecessors. France is responsible for 357, or 23% of all TAH-t implants worldwide.TUCSON, Ariz. – April 13, 2016 – Prof. Christian Cabrol implanted the first Total Artificial Heart in France on Sunday, April 13, 1986 at La Pitié- Salpêtrière Hospital. He also performed the first heart transplant in Europe (1968) and the first heart-lung transplant (1982). The leadership and work of La Pitié’s Cabrol, Prof. Alain Pavie and Prof. Pascal Leprince are recognized worldwide for their major contributions to cardiac surgery and patient care.

La Pitié accounts for 16% of the 1,586 SynCardia temporary Total Artificial Heart (TAH-t) implants and those of its direct predecessors.

Currently, SynCardia TAH-t implants in France are conducted at 13 SynCardia Certified Centers. The country logged a in SynCardia Heart implantations in 2015 over 2014.

While the SynCardia Heart was developed in the United States, it has been the work of La Pitié that helped further refine use of the device, patient-care protocol and recovery,” says Michael P. Garippa, President and CEO of SynCardia Systems. “La Pitié’, Bad Oeynhausen and Duisburg in Germany have mentored Top SynCardia Certified Centers worldwide.”

Leprince directs SynCardia Heart implantations at La Pitié. On December 23, 2014 he implanted the first 50cc TAH-t in the world which is the smaller version 70cc SynCardia Total Artificial Heart.

Early worldwide statistics and historical data reveal that the percentage of females receiving a 50cc SynCardia Heart is over 500% greater than females getting the larger 70cc SynCardia TAH-t. Pediatric patients, ages 21 and under, represent 11% of 50cc TAH-t implants. This is 175% more than the number of pediatric patients who make up 4% of all implants of the 70cc TAH-t. Though the 50cc numbers are small, they

The new 50cc SynCardia TAH-t is approved for use in Europe through the CE Mark and separately by Health Canada. The 50cc is available in the United States through an FDA-approved Investigational Device Exemption (IDE) clinical study and for compassionate or emergency use at SynCardia Certified Centers. (CAUTION – In the United States, the 50cc SynCardia Total Artificial Heart is an investigational device, limited by United States law to investigational use.)

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.

Together, the 70cc and 50cc versions make SynCardia TAH-t technology available to almost all adults and more adolescents. The weight of a human heart varies by body size and gender. It ranges between 250 and 350+/- grams.

The 70cc and 50cc SynCardia Hearts each weigh less than 250 grams. The SynCardia TAH-t and its direct predecessors are by far the most used total artificial hearts in the world. Of the 1,649 implants representing 13 designs from 1969 through April 7, 2016,

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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 1,580 implants of the SynCardia Total Artificial Heart account for over 530 patient years of life on the device. Since January 2012 more than 600 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart and received a successful donor heart transplant was nearly four years (1,373 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 275 patients, accounting for over 180 patient years of support.

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

Media Contact: Paris, France
Sylvain Thuaudet, MD,
st@ist-cardiology.com
Medical Director
Office: 2 31 95 11 07
Mobile: 607 528 395
IST cardiology

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