Minneapolis-based Sunshine Heart Inc. is in the final stages of a 20-patient feasibility test of an early version of an implantable wireless device to ease the heart's pumping load.
The C-Pulse Heart Assist System, when fully developed, will include an implanted driver (engine) and a cuff placed around the ascending aorta that inflates and deflates in synchronization with the heartbeat. A battery pack worn by the patient will power the driver by using a high-frequency electromagnetic field to transfer electricity through the skin without wires.
In the feasibility test, the cuff is implanted around the aorta but the battery and driver are housed outside the body in separate over-the-shoulder harnesses. A tube inserted through the abdomen connects the driver to the cuff; the tube also carries a wire from the battery to the driver.
Once the feasibility study is over, Sunshine Heart will submit data to the FDA and seek approval for a clinical trial involving 250 to 300 patients. These patients would test a next-generation version with a smaller driver and battery still outside the body but in a single unit on a single harness.
However, the company recently completed animal testing on a calf in partnership with the Texas Heart Institute in Houston in which the driver was implanted in the body along with the cuff, and powered via a wireless external battery. There is no timetable set for this version of the C-Pulse System, but the company notes that animal testing took place one year ahead of schedule.
More information is available at sunshineheart.com.
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