Press Release:

TUCSON, Ariz. – Dec. 12, 2006 – Led by Prof. Michael Weyand, MD, cardiac surgeon, Dr. Tandler, and members of the heart transplant team at the Center of Cardiac Surgery Erlangen-Nuremberg at Friedrich Alexander Hospital, began Certification training to implant the CardioWest™ temporary Total Artificial Heart (TAH-t) on December 4th.

The training is a four part certification process that includes the proctored implant of the center’s first CardioWest™ TAH-t on Thursday, December 14, 2006.

For some hospitals, it can take months to find an appropriate patient for the first proctored implant of the TAH-t. At the Friedrich Alexander Hospital, that patient is waiting right now. This patient is unlikely to survive more than a couple of weeks without a TAH-t implant or a human heart transplant.

Speaking from Monday’s training, Dr. Tandler said “We already have an excellent candidate for the artificial heart. We are excited to now have a device we can use to help him survive to transplant.” The surgery will be performed by Dr. Tandler and proctored by cardiovascular surgeon Latif Arusoglu, M.D. Arusoglu has performed over 100 TAH-t implants at the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany.

The CardioWest™ TAH-t is used as a “bridge to transplant” for transplant eligible patients who: 1) have both sides of their heart failing, 2) do not respond to other treatments, and 3) are at imminent risk of death.

In Europe, since July, stable patients have been able to be discharged with the EXCOR® TAH-t mobile driver. At-home care speeds recovery and eliminates in-hospital costs for this portion of their care. Living at home is also morale booster for patients, whose wait for a donor heart can take up to 18 months in Europe. The portable driver is about the size of an attaché case and weighs only 20 pounds. This driver allows many patients to leave home to shop, visit friends, and live a fuller life.

Now in its 50th year of cardiac surgery, the Friedrich Alexander Hospital has a robust cardiac program. In April 1969 the center performed the first coronary artery bypass in German history. In 2000 they started implanting VADs. Since 1999, the hospital has averaged 10-15 heart transplants annually. Once certified, the Friedrich Alexander Hospital will become the 20th heart transplant center in the world certified to implant the CardioWest™ TAH-t.

A New England Journal of Medicine paper published on August 26, 2004 (NEJM 2004; 351: 859-867), states that in the pivotal clinical study of the TAH-t, the one year survival rate for patients receiving the CardioWest TAH-t was 70 percent versus 31 percent for control patients who did not receive the device. One-year and five-year survival rate survival rates after transplantation among patients who had received a TAH-t as a bridge to transplant were 86 and 64 percent.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. In the 1990’s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest™ temporary Total Artificial Heart. SynCardia Systems, Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and surgeon Jack Copeland, M.D. The CardioWest™ TAH-t is the world’s first and only FDA and CE approved temporary Total Artificial Heart. The TAH-t has been implanted in over 650 patients.

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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 950 implants of the Total Artificial Heart, accounting for more than 230 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
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660