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Sunshine Heart Announces IDE Approval To Begin C-Pulse U.S. Clinical Feasibility Trial
Date:9/12/2008

SYDNEY, Australia, Sept. 12 /PRNewswire/ -- Sunshine Heart (ASX: SHC), a global medical device company focused on innovative heart assist technologies, today announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin its first U.S. clinical feasibility trial for the C-Pulse(TM) device in patients with moderate heart failure. C-Pulse is an implantable aortic cuff, designed as a cost effective heart assist therapy. The device is a uniquely positioned Class III heart failure therapy that offers an innovative intervention bridging the clinical gap between heart failure pacemakers and end stage therapies which potentially creates a new market opportunity.

Enrollment is expected to begin at six premiere U.S. 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, MD, of Ohio State University, and Patrick McCarthy, MD, 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 E.U. 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 U.S. pivotal study to support the submission of a marketing application for C-Pulse in the U.S.

Malcolm McComas, Chairman of the Board commented, "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. The agency's clinical approval of this treatment approach for moderate heart failure raises Sunshine Heart's profile as
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SOURCE Sunshine Heart
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