Press Release:

PD Dr. Andreas Hoffmeier, CardioWest patient Mike Gadiel and his wife, and Prof. Dr. T.D.T. Tjan, University Hospital Muenster.

TUCSON, Ariz. – Oct. 23, 2007 – Two months after being implanted with a Left Ventricular Assist Device (LVAD) to support his dying heart, Mike Gadiel’s heart began to fail again. On June 22, surgeons at University of Muenster saved his life by removing both the LVAD and his dying heart, and implanting their first CardioWest™ temporary Total Artificial Heart (TAH-t).

This implant marked University of Muenster’s completion of the CardioWest artificial heart certification program, started in 2006. The CardioWest artificial heart is the world’s first and only FDA and CE approved temporary artificial heart. It replaces both the left and right ventricles and pumps up to 9.5 liters per minute, which is more than any other approved device. University of Muenster is the 12th hospital in Europe and the 22nd in the world to become certified to implant the CardioWest artificial heart.

“Because of our CardioWest certification training, we were able to save a patient’s life who otherwise would have been out of options,” said Prof. Dr. Hans Scheld, head of the cardiothoracic department. “When it has been determined that a patient’s heart needs to be replaced, they need a matching donor heart. If one is not immediately available, the best solution for larger patients is the CardioWest temporary Total Artificial Heart.”

Gadiel was discharged on Sept. 1 from University of Muenster to wait for a donor heart at home. Since July 16, 2006, stable CardioWest patients in Europe have been able to recover at home thanks to the CE approved portable driver. With the driver, many patients are able to shop, travel and visit with friends. SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart, is currently working with the FDA to address the need for a discharge driver in the U.S.

The CardioWest artificial heart is approved as a bridge-to-transplant for patients dying from end-stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a donor heart, or a CardioWest artificial heart as a bridge-to-transplant.

The pivotal clinical study of the CardioWest artificial heart published in the New England Journal of Medicine (NEJM 2004; 351: 859-867) showed that 79 percent of patients receiving the artificial heart survived to transplant, the highest survival rate for any heart device in the world.

###

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
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