Sunshine Heart soars on C-Pulse CE Mark | Wall Street Beat

July 25, 2012 By MassDevice staff Leave a Comment

Sunshine Heart (ASX:SHC) is shining on Wall Street today after announcing European regulatory approval for its C-Pulse heart assist system, with SHC shares closing up nearly 14% on the news.

The Eden Prairie, Minn., and Sydney-based medical device company said the CE Mark means the C-Pulse system can be marketed for treating Class III and Class IV heart failure in the European Union and other countries that recognize the mark.

News of the approval for the C-Pulse outside-the-bloodstream heart pump sent SHC shares to $11.44 today, up 13.9%.

"The CE Mark approval includes our second generation driver, cuff and other components which we believe will improve the overall device performance and ultimately patients’ quality of life," CEO Dave Rosa said in prepared remarks.

Rosa told MassDevice.com in April that the U.S. market alone offers 1.5 million Class III patients. In Europe, that number is 3.7 million, according to Sunshine Heart.

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