A simulation video of the device is available at the company's Web site. The company has already conducted clinical studies in New Zealand and Australia. The latest FDA-approved feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital; The Ohio State Medical Center; Jewish Hospital University (University of Louisville); Hershey Medical Center of the Pennsylvania State University; University of Florida School of Medicine; and University of Alabama, Birmingham Medical Center. Following the trialâEUR(TM)s successful completion, Sunshine Heart will request a CE mark to begin marketing in Europe. In addition, it says it will seek FDA approval for a larger randomized U.S. pivotal study to support the submission of a marketing application for C-Pulse in the United States.
