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First US Institutional Review Board Approval
24 / 11 / 2008
Sunshine Heart, Inc. (ASX: SHC) announces that the Institutional Review Board (IRB) of the Jewish Hospital, University of Louisville, Kentucky has approved the hospital's participation in the US clinical trial for C-PulseTM. The trial has been fully approved by the US Food and Drug Administration (FDA). C-Pulse is a heart assist therapy for patients suffering from moderate heart failure.
The Jewish Hospital is the first US center to receive IRB approval for participation in the Company's clinical trial. The hospital has also completed all clinical training on the C-Pulse system including both surgical implant and site training. Once the requisite contracts are signed, the hospital will be able to begin clinical enrolment. Enrolment of patients in the trial is expected to commence this year.
The Principle Investigators at the Jewish Hospital are Dr. Mark S. Slaughter, Chief, Division of Thoracic and Cardiovascular Surgery and Director of Mechanical Assist Device Program and Dr. Sumanth Prabhu from the University of Louisville Health Science Center, Division of Cardiology. Dr Slaughter is an internationally renowned surgeon and a leader in the usage of heart assist devices for destination therapy.
"We are delighted to have received this approval and are fortunate to be associated with such exceptional physicians and their experienced support team at this outstanding university medical center," said Sunshine Heart CEO Don Rohrbaugh.
The Jewish Hospital is the first US center to receive IRB approval for participation in the Company's clinical trial. The hospital has also completed all clinical training on the C-Pulse system including both surgical implant and site training. Once the requisite contracts are signed, the hospital will be able to begin clinical enrolment. Enrolment of patients in the trial is expected to commence this year.
The Principle Investigators at the Jewish Hospital are Dr. Mark S. Slaughter, Chief, Division of Thoracic and Cardiovascular Surgery and Director of Mechanical Assist Device Program and Dr. Sumanth Prabhu from the University of Louisville Health Science Center, Division of Cardiology. Dr Slaughter is an internationally renowned surgeon and a leader in the usage of heart assist devices for destination therapy.
"We are delighted to have received this approval and are fortunate to be associated with such exceptional physicians and their experienced support team at this outstanding university medical center," said Sunshine Heart CEO Don Rohrbaugh.