Sunshine Heart has presented the results of a US Food and Drug Administration-approved feasibility study of the C-Pulse heart assist system.
The C-Pulse system uses the intra-aortic balloon counter-pulsation principle to reduce the workload required to pump blood throughout the body, and increase blood flow to the coronary arteries.
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In the feasibility study, 18 patients with ACC/AHA Stage C New York Heart Association Class III heart failure and two patients with ambulatory Class IV heart failure were implanted with the C-Pulse system.
It was found that after six months, C-Pulse therapy produced considerable improvements in class reduction, quality of life and left ventricular ejection fraction.
The primary endpoints included device-related death, neurological dysfunction, aortic disruption, myocardial infarction, major infection and any other device-related adverse events through six months.
National co-lead principal investigator William Abraham said a prospective multicentre trial to further assess the safety and efficacy of C-Pulse system is planned.
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By GlobalDataSunshine Heart CEO Dave Rosa said the company plans to work with the FDA to gain permission to initiate a pivotal trial in the US next year.
