Press Release:

Dr. Latif Arusoglu, Senior Physician/Heart Surgeon, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany

TUCSON, Ariz. – June 18, 2009 – On June 12, the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, performed the 800th implant of the SynCardia temporary CardioWest™ Total Artificial Heart. The 60-year-old patient, who was suffering from biventricular failure, was listed in stable condition post-implant.

“This was our 129th implant of the Total Artificial Heart,” said implanting surgeon Dr. Latif Arusoglu. “The Total Artificial Heart is the only device that pumps up to 9.5 L/min through both ventricles, helping us to rescue the sickest of the sick.”

Dr. Arusoglu brought the Total Artificial Heart to the Heart & Diabetes Center NRW and performed the hospital’s first implant in 2001. As an instructor for SynCardia’s Certification Program, Dr. Arusoglu proctors top European transplant centers during their first implant. The Heart & Diabetes Center NRW has performed more Artificial Heart implants than any other center in Germany.

Prof. Jan Gummert, M.D., Director of the Clinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany

“Our Total Artificial Heart patients can wait up to 2 years for a matching donor heart,” explained Prof. Jan Gummert, M.D., Director of the Clinic for Thoracic and Cardiovascular Surgery. “The portable driver allows stable patients to enjoy an active lifestyle at home and in their communities, similar to people with healthy human hearts.”

From 2003-2006, the Heart & Diabetes Center NRW pioneered the clinical study of the European portable driver, which resulted in the CE Mark. European Total Artificial Heart patients discharged on the portable driver account for more than 50 years of life outside the hospital without a human heart.

In the U.S., an FDA-approved discharge driver has never been available. Total Artificial Heart patients – who are otherwise healthy – often spend months confined to the hospital while they wait for a matching donor heart.

This summer, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the new 12-lb Freedom® discharge driver. Once the study is approved, for the first time in U.S. history, stable Total Artificial Heart patients will be able to leave the hospital and enjoy life at home while they wait for a matching donor heart.

###

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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660