fda completes review of c-pulse®

Sunshine Heart Announces FDA Completes Review of C-Pulse® Feasibility Data
Next Up: Submission of U.S. Pivotal Trial Protocol

Sydney, Australia and Eden Prairie, MN: 14 March, 2012: Sunshine Heart, Inc. (NASDAQ: SSH, ASX: SHC) today announced that the Center for Devices and Radiological Health(CDRH) of the United States Food and Drug Administration(FDA) completed its review of Sunshine Heart’s Investigation Device Exemption(IDE) for the C-Pulse Heart Assist System feasibility trial. The FDA notified the Company that it has met the requirements of FDA regulation 21CFR 812.150(b)(5) and that no other information is required at this time.

Following the communication from the FDA, Dave Rosa, CEO of Sunshine Heart commented, “We are pleased that we have fulfilled the agency’s requirements and look forward to working with the FDA regarding the submission of our pivotal trial protocol.”

The Company continues to expect that the C-Pulse U.S. pivotal trial will commence in the third quarter as previously forecast.

Not sure about our crazy market but US investors will understand and like this news imo