Press Release:

TUCSON, Ariz. – June 8, 2006 – Ohio State University Medical Center has joined a handful of institutions worldwide certified to implant a federally approved temporary artificial heart in patients awaiting a heart transplant.

Dr. Benjamin Sun, OSU Medical Center’s chief of cardiothoracic surgery, and his team performed central Ohio’s first implantation of a CardioWest temporary Total Artificial Heart (TAH-t) on May 26, 2006. The surgery went smoothly “with no big surprises,” Sun said.

The patient, a 58-year-old Ohio man, is expected to progress and be well enough to be a candidate for transplantation in the near future, said Dr. Sai Sudhakar, a cardiothoracic surgeon who is part of the surgical implant team and leads the patient’s overall care.

Sun and Sudhakar were among a team of physicians, nurses and perfusionists who underwent training for implantation of the device earlier this spring at University Medical Center in Tucson, AZ. The artificial heart manufacturer, SynCardia Systems Inc., is based in Tucson.

“We’re fortunate to be in the early group selected to do this as part of the initial rollout of the artificial heart,” Sun said. “We are able to use the device to make a poor candidate for cardiac transplantation into a good candidate.”

The patient had suffered a massive heart attack, was urgently bypassed and had been treated with other mechanical support devices that “just weren’t enough,” Sudhakar said. The TAH-t pumps up to 9.5 liters of blood per minute through both ventricles – more than any other device – helping to rejuvenate vital organs that have atrophied due to a failing heart.

Sun described the artificial heart as a “complicated but simple device” that moves much more blood than the more widely used ventricular assist devices, which are attached to a failing heart to pump blood. Removing a heart to replace it with an artificial heart “is a drastic step that is difficult for us as clinicians and for patients to accept, but the data show that its success rate is really quite impressive, and better than those supported with ventricular assist devices in certain groups of patients. This is a new therapy that only a few hospitals are able to offer to the sickest patients whose only other chance for survival is an urgent heart transplant,” Sun said.

A New England Journal of Medicine paper published in August 2004 about the pivotal study of the TAH-t reported that the one-year survival rate following human heart transplant for patients receiving the CardioWest temporary Total Artificial Heart was 70 percent, compared to 31 percent for control patients who did not receive the device.

OSU Medical Center is one of just four medical institutions in the United States, and seven others worldwide, currently fully certified to implant the CardioWest TAH-t. The others in the United States are Virginia Commonwealth University, the Cleveland Clinic and University Medical Center in Tucson, Ariz.

Sun’s previous work with transplantation and cardiac mechanical support devices helped secure OSU Medical Center’s selection for certification. Sun, also director of cardiac transplantation and mechanical support, leads a cardiac care team at Ohio State’s Richard M. Ross Heart Hospital with extensive transplant experience. The highly specialized physicians, nurses and technicians also are caring for patients supported by 10 different mechanical support devices, many of which act as pumps for weakened ventricles.

The CardioWest TAH-t is a pneumatic, biventricular, implantable bridge-to-transplant system for full cardiac replacement, taking the place of the failing heart in patients at imminent risk of death. The TAH-t is a modern version of the Jarvik-7 artificial heart of the 1980s. The TAH-t is the only total artificial heart approved by the U.S. Food and Drug Administration, Health Canada and Communite Europeenne.

SynCardia Systems was formed in 2001 by Dr. Marvin Slepian, engineer Richard G. Smith and Dr. Jack Copeland, considered the “father” of total artificial heart therapy in the United States. All three, along with other medical professionals, are instructors for the TAH-t certification training program.

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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