Sunshine Heart has received the US Food and Drug Administration (FDA) approval for investigational device exemption (IDE) supplement for the C-Pulse Heart Assist System
Using intra-aortic balloon counter-pulsation technology, the C-Pulse Heart Assist System assists the left ventricle by reducing the workload required to pump blood throughout the body.
Once implanted, the C-Pulse cuff is positioned on the outside of the patient’s ascending aorta above the aortic valve.
An ECG sensing lead is then attached to the heart to determine timing for cuff inflation and deflation in synchronization with the heartbeat.
Sunshine Heart said, because the C-Pulse System remains outside the blood system, there is potentially less risk of blood clots and stroke in comparison to other mechanical devices that reside or function in the bloodstream.
The C-Pulse feasibility study is primarily designed to assess safety and provide indications of performance of this device in moderate to severe heart failure patients who suffer from symptoms such as shortness of breath and reduced mobility.
The FDA-approved IDE feasibility study is available to men and women between the ages of 18 and 75 who suffer from Class III/ambulatory Class IV heart failure and for whom standard drug therapy has failed.
Sunshine Heart CEO Dave Rosa said they are pleased that the FDA has approved their request to continue to offer this therapy to additional patients that meet the appropriate criteria while they collect the follow-up data from their initial twenty patients.
"This will allow not only existing centers to continue to offer the therapy but it will also enable us to add two additional sites that have expressed interest in participating," Rosa said.
Once the six-month follow-up with the 20th patient is completed, Sunshine Heart will submit the feasibility data to the FDA to seek FDA approval for the pivotal trial protocol.