| 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.
Dr. Michel Carrier
Montreal Heart
Institute
“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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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 715 implants of the CardioWest, accounting for more than 125 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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