|C-Pulse Heart assist system--Courtesy of Sunshine Heart|
Sunshine Heart ($SSH) has temporarily suspended the clinical trial of its C-Pulse Heart assist system after four patients died during the trial, but says that the deaths were not related to the device.
The FDA has told the company to file a document discussing the reasons for the suspension and plans for study resumption. Sunshine says it will file the document by March 16; it has a 30-day review period.
"We are confident this matter will be resolved in a very short timeframe. While the current data suggest these incidents are non-device related, we have decided that in the absolute interest of patient safety, having a temporary pause in enrollment is the right course of action while we work with the FDA to discuss the findings. We remain excited by the increasing number of patients who are being presented for study review and are pleased that the screening process for enrollment will continue while we resolve this matter," said Sunshine Heart CEO Dave Rosa in a statement.
Sunshine Heart said in its release that two of the deaths have been deemed non-device related by an independent Clinical Events Committee, and it has evidence that the other two were non-device related as well.
The move to suspend the trial is in accordance with the study protocol, which calls for a suspension if more than three of the first 20 subjects die for any reason. Sunshine Heart says that trial enrollment was approaching 100 patients and had a goal of 388 subjects. The estimated primary completion date was April 2016, but that was prior to the suspension, according to ClinicalTrials.gov.
More information will be made available during the company's March 17 earnings call.
The C-Pulse is designed to stop deterioration of a diseased heart, or in a more positive scenario, prevent altogether the need for late-stage heart failure therapies such as left ventricular assist devices and artificial heart transplants. C-Pulse patients must carry an external driver with sensing leads that connect to the device via an incision in the abdomen.
Sunshine says that it "utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries."
The device has an investigational device exemption from the FDA, meaning it is approved for use in clinical trials, and earned a CE mark for commercialization in Europe in 2012.
The C-Pulse is Sunshine Heart's primary product. In its most recent quarter, the company reported a net loss of $6.1 million on sales of $59,000.
- read the release
- get more about the trial from ClinicalTrials.gov (last updated in September 2014)