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C-Pulse Begins Clinical Trial

A 20-patient study is under way in the United States to explore the efficacy of C-Pulse heart assist system implants. The system, manufactured by Sunshine Heart is designed to increase blood flow to the body and to the heart muscle, thereby improving quality of life for patients with moderate heart failure. The device is implanted with minimally invasive techniques and does not come into contact with blood.

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.

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