FDA’s Green Light For U.S Pivotal Trial Of C-Pulse® System

In short

We recently announced Sunshine Heart, Inc.’s gaining of FDA’s conditional nod to commence a flagship IDE study into the use of its C-Pulse® Heart Assist System. Now it seems the agency has satisfied itself enough to remove the conditionality from the study. This means it’s ready to go.


The C-Pulse Heart Assist System, works by what can best be described as an extra-aortic counterpulsation. The simple principle is that this will assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries.

Sunshine Heart plans to initiate the pivotal trial in North America in the fourth quarter of 2012. 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 randomised to optimal medical therapy across 30-40 clinical sites.

In July, Sunshine Heart announced positive 12-month extended follow-up data from its preliminary feasibility study of the C-Pulse Heart Assist System. Extended data included positive efficacy trends with continued improvements in NYHA Class reduction, MLWHF Quality of Life score, and six minute hall walk. There were no additional patients with device-related serious adverse events (SAEs) in this 12 month time frame.

Also in July, the Company achieved CE Mark certification, allowing commercialization of the device in Europe. The Company has been targeting leading LVAD and transplant centers in the EU.

The Company estimates enrollment for the event-driven pivotal trial will take approximately 2.5 years. The primary endpoint of the trial will be reduction in worsening heart failure events leading to hospitalisation, advanced heart failure therapies and heart failure related mortality. A one year safety follow-up is expected.

Company comments

“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-hospitalisation rates plaguing the U.S. healthcare system today. All of us at Sunshine Heart are committed to expediting this next phase of technology advancement,” commented Dave Rosa.

Regulatory status

C-Pulse is limited by Federal (or United States) Law to Investigational use.

Source: Sunshine Heart Inc., MarketWire