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.
Greatbatch to proceed with Swiss ops shuttering
Greatbatch (NYSE:GB) said the 3-week window for employees of its Swiss operations to comment on plans to largely shutter 2 plants is closed, meaning "most major functions" will be moved to Indiana and Mexico by the end of 2013. Greatbatch said it expects to book charges on the restructuring of $14 million to $32 million over the next 18 months, not including $10 million to $14 million in non-cash write-offs.
VC fund New Enterprise Associates drums up a cool $2.6B
Yes, that’s $2.6 BILLION.
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