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FDA Grants Full Approval of US Clinical Trial
21 / 11 / 2008
Sunshine Heart, Inc. (ASX: SHC) announces that it has received full approval from the United States Food and Drug Administration (FDA) to begin its first US clinical trial for C-PulseTM, a heart assist therapy for patients suffering from moderate heart failure.
The Company had previously announced on 12 September 2008 that it had received conditional approval from the FDA to begin its US clinical trial. Whilst the conditional approval permitted the Company to start its US clinical trial, it was required to address several conditions which related to the clinical protocol, patient record keeping and device labeling. The Company has now addressed these conditions to the satisfaction of the FDA.
CEO Don Rohrbaugh said: "We are currently finalizing Institutional Review Board (IRB) approval and the contractual arrangements with the six approved clinical centers and we are still anticipating patient enrollment to commence this year. It should be noted that C-Pulse is the first approved heart assist system to enter into a FDA approved clinical trial for the unmet clinical need of moderate heart failure patients."
The approved clinical centers for the C-Pulse clinical trial are all university-based teaching hospitals with a heart failure focus. They include Northwestern University, Chicago; Ohio State University, Columbus; Pennsylvania State University, Hershey; University of Louisville, Kentucky; University of Alabama, Birmingham and University of Florida, Gainesville.
The Company had previously announced on 12 September 2008 that it had received conditional approval from the FDA to begin its US clinical trial. Whilst the conditional approval permitted the Company to start its US clinical trial, it was required to address several conditions which related to the clinical protocol, patient record keeping and device labeling. The Company has now addressed these conditions to the satisfaction of the FDA.
CEO Don Rohrbaugh said: "We are currently finalizing Institutional Review Board (IRB) approval and the contractual arrangements with the six approved clinical centers and we are still anticipating patient enrollment to commence this year. It should be noted that C-Pulse is the first approved heart assist system to enter into a FDA approved clinical trial for the unmet clinical need of moderate heart failure patients."
The approved clinical centers for the C-Pulse clinical trial are all university-based teaching hospitals with a heart failure focus. They include Northwestern University, Chicago; Ohio State University, Columbus; Pennsylvania State University, Hershey; University of Louisville, Kentucky; University of Alabama, Birmingham and University of Florida, Gainesville.