Press Release:

Dr. Aly El-Banayosy, the innovator behind the CE portable driver for the artificial heart.

TUCSON, Ariz. – July 17, 2008 – On July 10, the Penn State Hershey Heart and Vascular Institute’s Mechanical Circulatory Support Team performed its first 2008 implant of the CardioWest™ temporary Total Artificial Heart on a 57-year-old male patient. The Medical Center implanted its first CardioWest artificial heart in May 2007 as a bridge to human heart transplant. The latest implant follows the recent arrival of Dr. Aly El-Banayosy, the new Director of the Penn State Hershey Heart and Vascular Institute’s Intensive Care Unit and Medical Director of Mechanical Circulatory Support.

“We are thrilled to have Dr. Banayosy join our team to help us build a national model for comprehensive heart and vascular care,” said Dr. Walter Pae, Professor and Director of Cardiothoracic Surgery at Penn State Milton S. Hershey Medical Center. “In Germany, Dr. Banayosy pioneered the use of the European portable driver for discharging artificial heart patients. His experience working with more than 100 CardioWest patients is invaluable.”

Previously, Dr. Banayosy was the Medical Director of Mechanical Circulatory Support at the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany. The hospital has implanted more than 115 CardioWest artificial hearts, in addition to performing nearly 5,000 open heart procedures yearly.

Dr. Walter Pae, Director of Cardiothoracic Surgery at Penn State Milton S. Hershey Medical Center

From 2003-2006, Dr. Banayosy pioneered the clinical study of the European portable driver that led to CE mark approval on July 17, 2006. “Without Dr. Banayosy’s hard work and innovation, there would be no European portable driver,” said Rodger Ford, President and CEO of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart.

“We can describe the quality of life for European patients supported by the portable driver as near normal,” said Dr. Banayosy. “They are very active. They can go shopping, drive in cars, go for holidays, for vacations and so on. I eagerly await the FDA study of the Companion Drive System.”

Before the end of the year, SynCardia Systems, Inc. will submit an application to the FDA to conduct an IDE clinical study of the Companion Drive System. The Companion Drive System is designed for use in both the hospital and for discharge. Penn State Hershey Medical Center will be one of 22 CardioWest certified hospitals to participate.

“I want to ensure that all of our patients have access to the best heart devices in the world,” said Dr. Banayosy. “For patients dying from end-stage biventricular failure, the CardioWest artificial heart is an amazing device.”

Last month, Penn State Hershey’s Mechanical Circulatory Support program become one of only a handful of programs in the United States and the only program in central Pennsylvania to earn the Joint Commission’s Gold Seal of ApprovalTM for implanting VADs as destination therapy for patients with advanced heart failure.

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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