AMTAC Certification Services has granted CE mark for CellAegis Devices's autoRIC device.
The CE mark allows CellAegis to sell autoRIC Device to 32 member countries and seven cooperating countries of the european economic area, under European medical device directive 93/42/EEC.
CellAegis’ autoRIC device, which automates remote ischemic conditioning (RIC) at the point of care, is designed for use in acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home.
CellAegis Devices CEO Rocky Ganske said the CE mark validates the safety of the autoRIC device, and the company is looking forward to initiate a clinical testing program in the EU and US later in second half of 2012 to add to the growing body of evidence in support of RIC.
"We believe the autoRIC Device has the potential to revolutionize the treatment of ischemic-related reperfusion injury by providing a noninvasive and reliable therapeutic option to be used alongside current standards of care," Ganske added.
The randomized study, which will enroll patients who have undergone elective PCI and coronary artery bypass graft surgery, is designed to measure decrease in heart damage and mortality in over 1000 patients to be enrolled in multiple clinical centers in the UK, Denmark, Germany and the US.