July 17, 2008

Innovator of European Portable Driver for Artificial Heart Joins Penn State Hershey Medical Center As Director of Heart & Vascular ICU

On July 10, the Penn State Hershey Heart and Vascular Institute's Mechanical Circulatory Support Team performed its first 2008 implant of the CardioWest(TM) 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.

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 Approval(TM) for implanting VADs as destination therapy for patients with advanced heart failure.

The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. Originally designed as a permanent replacement heart, the CardioWest is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival is dependent upon receiving a matching donor heart, or a CardioWest artificial heart as a bridge-to-transplant.

In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the CardioWest survived to transplant. This is the highest bridge-to-transplant rate for any heart device in the world. There have been more than 740 implants of the CardioWest, accounting for more than 135 patient years of life on the artificial heart.