Sunshine Heart's C-Pulse System approved for trial

Sunshine Heart Inc. has announced that the US Food and Drug Administration granted it unconditional approval to start its pivotal US trial for its flagship C-Pulse Heart Assist System.

C-Pulse System is an implantable, non-blood contacting, heart assist therapy for treating moderate to severe heart failure.

“We are pleased to have expeditiously completed the approval process with the FDA. We are excited to evaluate the C-Pulse System’s potential in treating patients suffering from Class III and ambulatory Class IV heart failure,” said Sunshine Heart CEO Dave Rosa.

The company said it contacted a number of heart failure centers in the US, and plans to start trial during the fourth quarter. Sunshine’s C-Pulse Heart Assist System received the CE Mark in July 2012, and is currently an investigational device in the US.