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Hershey
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Sunshine Heart's C-Pulse heart-assist device has been implanted in a sixth trial patient, with Pennsylvania State University performing its first such procedure under US regulatory approval.
Medical device maker Sunshine Heart reports its first two American C-Pulse patients cleared three-month follow-ups, booked initial reimbursement revenue from an Ohio trial site, and outlines coming CE Mark and FDA steps.
Sunshine Heart won complete US regulator clearance to run its first American trial of the C-Pulse heart device, having satisfied conditions attached to September's conditional clearance; enrolment of trial participants was anticipated that year.
ASX-listed medical device company Sunshine Heart appointed Melbourne heart transplant specialist Professor Don Esmore to its medical advisory board, which already includes academics from Penn State, Stanford and the Cleveland Clinic.