The FDA expansion protocol approval permits the company to implant an additional 20 patients and to add two new study sites. The company recently revealed that the C-Pulse Heart Assist System has been implanted in 20 patients globally.
According to the company, 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.
Once the six-month follow-up with the twentieth patient is completed, Sunshine Heart will submit the feasibility data to the FDA. Shortly thereafter, the company will seek FDA approval for the pivotal trial protocol.
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.
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. In addition, it increases blood flow to the coronary arteries.
Combined, these potential benefits may help reverse the heart failure process or maintain the patient's current condition, thereby preventing the need for later stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants.
Dave Rosa, CEO of Sunshine Heart, said: â€œWe are pleased that the FDA has approved our request to continue to offer this therapy to additional patients that meet the appropriate criteria while we collect the follow-up data from our 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.â€
Will the approval benefit the firm?
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