FDA Approval for C-Pulse US Clinical Trial
Sunshine Heart says the US regulator has conditionally cleared its first American trial of the C-Pulse heart assist device, with about twenty patients to enrol across six US hospitals from late 2008.
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| Name | Role | Sources |
|---|---|---|
| Dr Patrick M McCarthy | Chairman | GBS Ventures (12 Sep 2008), GBS Ventures (22 Feb 2007) |
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Sunshine Heart says the US regulator has conditionally cleared its first American trial of the C-Pulse heart assist device, with about twenty patients to enrol across six US hospitals from late 2008.
Two American heart failure specialists have agreed to serve as co-principal investigators for Sunshine Heart's C-Pulse feasibility trial, which the company says adds credibility as it prepares a wider US study in 2007.