Sunshine Heart, a medical devices company based in Australia has received full approval from the United States Food and Drug Administration (FDA) to begin its first US clinical trial for ‘C-Pulse’.
‘C-Pulse’ is a heart assist therapy for patients suffering from moderate heart failure. The company had previously received conditional approval from the FDA to begin its US clinical trial. The conditional approval permitted the company to start its US clinical trial. However, the company required the complete approval to address problems related to the clinical protocol, patient record keeping and device labeling.
“We are currently finalizing Institutional Review Board (IRB) approval and the contractual arrangements with the approved clinical centers. 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,” said Mr Don Rohrbaugh, CEO, Sunshine Heart.
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.
The approved clinical centers for the ‘C-Pulse’ clinical trial are all university-based teaching hospitals with a focus on heart failure. They are Northwestern University, Chicago; Ohio State University, Columbus; Pennsylvania State University, Hershey; University of Louisville, Kentucky; University of Alabama, Birmingham and University of Florida, Gainesville