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SynCardia Systems, Inc.

Press Release:

Eight of The Best Total Artificial Heart Centers Honored by SynCardia

Eight SynCardia Certified Centers represented by leading cardiac surgeons were honored for their 2015 achievements in saving patients dying from end-stage biventricular (both sides) heart failure with the SynCardia temporary Total Artificial Heart.

Eight SynCardia Certified Centers, represented by leading cardiac surgeons, were honored for their 2015 achievements in saving patients dying from end-stage biventricular (both sides) heart failure with the SynCardia temporary Total Artificial HeartEight SynCardia Certified Centers, represented by leading cardiac surgeons, were honored for their 2015 achievements in saving patients dying from end-stage biventricular (both sides) heart failure with the SynCardia temporary Total Artificial Heart TUCSON, Ariz. – May 10, 2016 – The eight honored SynCardia Certified centers were presented awards during the 36th Annual Meeting of the International Society of Heart & Lung Transplantation (ISHLT), April 27-30, 2016, in Washington D.C. The awards were not part of the ISHLT official program.

These Certified Centers represent four countries: the United States, France, Germany and Italy.

“We are fortunate to work with these highly skilled surgeons and experienced centers that use the SynCardia temporary Total Artificial Heart (TAH-t) to give their patients a second chance at life,” says Michael P. Garippa, CEO and President of SynCardia Systems, Inc.

World Volume Leader: 2013 - 2015

Cedars-Sinai Heart Institute, United States, has implanted 75 Total Artificial Hearts, in the shortest time period than any SynCardia Certified Center in history. Represented by Dr. Francisco Arabia, Cedars-Sinai was recognized as the SynCardia World Leader through implanting more hearts annually in 2013, 2014 and 2015 than any other center worldwide.

World Leader Total Implants

With 30 years of experience with the SynCardia TAH-t, Hôspital de La Pitié Salpètrière, France, has implanted 251 Total Artificial Hearts, more than any other hospital. Prof. Pascal Leprince, who directs the program, implanted the world’s first 50cc SynCardia Heart on December 23, 2014. The smaller version of SynCardia technology is designed for women, men of smaller stature and many adolescents.

50cc TAH-t World Leader

Prof. Dr. med. Gero Tenderich has led Evangelisches Krankenhaus Duisburg-Nord, Germany, in the implantation of six 50cc* SynCardia Hearts – more than any other center. In addition, he proctored five 50cc implant surgeries for new users of this smaller size.

Duisburg-Nord has also implanted 40 70cc TAH-t’s for a total of 46 SynCardia Hearts. Almost all TAH-t implants were from 2012 to 2016. Together, the 70cc and the 50cc Hearts are designed to accommodate almost all adults and more adolescents because of the 50cc’s smaller size.

Distributor of the Year

IST Cardiology, France, has worked to make France a leader in SynCardia TAH-t implantations. From 2013 to 2015, France has logged a 71% increase in implants with its 13 SynCardia Certified Centers, accounting for 22%, or 359, of all SynCardia TAH-ts and its direct predecessors.

Resurgence Awards

These three centers showed outstanding growth in SynCardia TAH-t implants over an 18-month period ending December 2015:

  • A.O.R.N. dei Colli Monaldi-Cotugno-CTO, Naples, Italy, led by Dr. Ciro Maiello
  • Centre Hospitalier Universitaire de Rennes, France, led by Dr. Erwan Flecher
  • Penn State Hershey Medical Center, United States, led by Dr. Walter Pae

Milestone Award

A SynCardia Certified Center in Ohio, United States, implanted more than 25 SynCardia Hearts.

*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 temporary Total Artificial Heart is an investigational device, limited by United States law to investigational use.

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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.

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