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News Breaks | | | | August 30, 2012 | | 13:23 EDT |  | SSH | Sunshine Heart submits IDE with FDA
Sunshine Heart has filed its submission for an Investigational Device Exemption with the U.S. FDA. The Company's IDE submission relates to the proposed use of the C-Pulse Heart Assist System for patients suffering with moderate to severe heart failure. If successful, the Company believes this trial should provide the data required by the FDA to permit approval, which would allow the Company to commercialize the C-Pulse System in the U.S. This pivotal trial follows the FDA's review of the six month safety and efficacy data reported from the 20-patient North America feasibility study. The proposed primary endpoint is reduction of events such as re-hospitalization due to worsening heart failure and heart failure-related mortality. The study will evaluate results for patients that receive the C-Pulse System in comparison to a control group that is managed on optimal medical therapy. | |
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News For SSH From The Last 14 Days Check below for free stories on SSH the last two weeks. |
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| May 14, 2013 | | 06:09 EDT |  | SSH | Sunshine Heart reports Q1 EPS (47c), consensus (51c)
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