Press Release:

Discharge Driver Brings Sharp and Montreal Heart Institute
Back to the CardioWest™ Artificial Heart

New Discharge Driver Designed to Enhance Patient Quality of Life and Lower Hospital Costs

Dr. Michel Carrier, Montreal Heart Institute

Dr. Michel Carrier, Montreal Heart Institute

TUCSON, Ariz. – May 22, 2008 – On May 1 and 2, Sharp Memorial Hospital in San Diego and Montreal Heart Institute in Quebec, Canada, completed the first phase of certification training for the CardioWest™ temporary Total Artificial Heart (TAH-t) at University Medical Center in Tucson, Arizona.

“We are very excited about returning to the CardioWest program,” said Dr. Michel Carrier from Montreal Heart Institute. “The highly anticipated Companion Driver System will allow us to discharge our stable CardioWest patients to recover at home while they wait for a donor heart transplant. Discharge greatly enhances the patient’s quality of life while limiting costs for in-hospital patient care.”

Since July 17, 2006, stable CardioWest patients in Europe have enjoyed a much better quality of life than CardioWest patients in North America because of the CE approved portable driver. Discharge drivers allow stable artificial heart patients to shop, travel and enjoy a quality of life comparable to people with human hearts.

Today, CardioWest patients in North America are confined to the hospital while they wait for a matching donor heart because the only FDA-approved driver is the hospital-based, 400-pound “Big Blue.”

Later this year, artificial heart manufacturer SynCardia Systems, Inc., will submit an application to the FDA to conduct an IDE clinical study of the Companion Driver System at 22 U.S. hospitals. The Companion Driver System is designed for use in both the hospital and for discharge. The Discharge Caddy is approximately 1/10 the size of “Big Blue”. SynCardia has been working with the FDA and Medicare for more than a year to bring this new technology to its patients.

From 1985 to 1987, Dr. Carrier completed a fellowship studying with renowned artificial heart surgeon Dr. Jack Copeland. Montreal Heart Institute performed its first implant of the artificial heart in 1987. Its most recent implant was in 2006.

Sharp Memorial Hospital, led by Dr. Walter Dembitsky, Medical Director of Cardiac Surgery and Mechanical Circulatory Support, also performed its first implant in 1987. Sharp Memorial’s most recent implant was in 2004. The 67-year-old patient received the CardioWest artificial heart after a failed heart transplant. After approximately 60 days on the artificial heart, the patient received a second donor heart transplant. Today, he is healthy and enjoying life.

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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

 

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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