Dr. Aly El-Banayosy is the innovator behind
the European portable driver for the
CardioWest artificial heart. The portable
driver allows stable artificial heart patients
in Europe to wait at home for a donor heart for
transplant instead of being confined to the hospital.
Hershey, Penn. – 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.
Dr. Walter Pae, Director
of Cardiothoracic Surgery
at Penn State Milton S.
Hershey Medical Center
“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.
“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.
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 Driver 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 Driver 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™ 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.
Media Contact:
SynCardia Systems,
Inc.
Director of Communications
Don Isaacs
Cell: (520) 955-0660
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