Oct 1 (Reuters) - Sunshine Heart Inc said its flagship device to treat heart failure was approved for trials in the United States, sending its shares up as much as 15 percent.
The U.S. Food and Drug Administration's investigational device exemption allows a company to use an experimental device in a clinical study to collect safety and efficacy data.
Sunshine's heart assist system, C-Pulse Heart Assist, reduces the workload required to pump blood throughout the body while increasing blood flow to the coronary arteries.
Unlike similar devices, C-Pulse is implanted outside the bloodstream, reducing the risk of blood clots that can lead to strokes.
Sunshine Heart plans to start a pivotal trial in North America in the fourth quarter of 2012.
The company, which expects the trial to take about two and a half years, said the main goal will be to reduce heart failure.
The device was approved in Europe in July.
Sunshine Heart shares were up 7 percent at $8.94 on the Nasdaq on Monday. They rose to $9.80 earlier in the day.
(Reporting by Prateek Kumar in Bangalore; Editing by Don Sebastian)
Keywords: SUNSHINE FDA/HEARTPUMP