FDA Approves Pivotal US Trial for Sunshine Heart’s C-Pulse® Heart Assist System

Sunshine Heart Inc. (ASX:SHC,NASDAQ:SSH) announced that the FDA granted it unconditional approval to begin the pivotal US trial for its C-Pulse® Heart Assist System. The company plans to start the trial before the end of the year.

As quoted in the press release:

The Company has contacted a number of leading heart failure centers in the U.S. and to date is encouraged by the positive response to participate in the trial. The trial design will consist of 388-patients of which half will be implanted with the C-Pulse System. The other half will be randomized to optimal medical therapy across 30-40 clinical sites.

Dave Rosa, CEO of Sunshine Heart, commented:

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. We also are eager to evaluate its clinical and economic impact in reducing re-hospitalization rates due to worsening heart failure as this represents the highest and most costly re-hospitalization rates plaguing the U.S. healthcare system today. All of us at Sunshine Heart are committed to expediting this next phase of technology advancement.

Click here to read the full Sunshine Heart Inc. (ASX:SHC,NASDAQ:SSH) press release.