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news.Sunshine Heart, a medical device company focused on heart assist technologies, has received conditional approval of an investigational device exemption from the FDA to begin its first US clinical feasibility trial for the C-Pulse device in patients with moderate heart failure.
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Enrollment is expected to begin at six US medical institutions by the end of 2008. The objective of the trial is to evaluate the safety and efficacy of C-Pulse in 20 patients currently suffering from moderate heart failure.
William Abraham of Ohio State University, and Patrick McCarthy of Northwestern University Medical Center, will serve as national co-lead principal investigators. Each patient’s performance with C-Pulse will be closely monitored over a six month follow-up period.
Following the trial’s successful completion, the company will request CE mark approval to market C-Pulse in the EU and other international countries that honor CE mark label claims for device safety. In addition, the company will seek FDA approval for a larger randomized US pivotal study to support the submission of a marketing application for C-Pulse in the US.
Malcolm McComas, chairman of the board at Sunshine Heart, said: “We are proud to announce that Sunshine Heart is the first company to receive FDA approval to run a clinical trial evaluating a non-blood contacting heart assist device.”