CellAegis Devices has obtained Health Canada's marketing authorization for its proprietary, automated, noninvasive device autoRIC device for remote ischemic conditioning (RIC).
The Medical Device Class III license, granted by Health Canada, allows the company to provide non-invasive RIC for adult patients undergoing cardiothoracic surgery or interventional cardiothoracic procedures, as well as for patients with evolving myocardial infarction.
The portable device is intended for use in a hospital, ambulance or home as directed by a healthcare professional and offers a safe and accurate method to automate RIC at the point of care.
Placed around the arm, the device is compatible with current standard-of-care treatments and delivers four cycles of simple-to-administer treatment in less than 40 minutes, according to the company.
The Hospital for Sick Children cardiology head Dr Andrew Redington and University of Toronto cardiac surgery division chair professor Christopher Caldarone said in a joint statement that RIC activates innate mechanisms of metabolic protection and has the potential to revolutionize the treatment of cardiovascular disease.
"We believe a reliable and automated method of providing RIC offers the potential for significant reductions in myocardial injury with an extremely favorable risk/benefit ratio at a fraction of the cost of other high-tech therapies benefiting the patient, payor, and the provider," Redington and Caldarone added.
CellAegis is planning to start device commercialization in Canada in the second half of 2013 and looking forward to incorporate the autoRIC Device in multiple clinical trials throughout the global cardiology community.
The company said it will display its device at the American College of Cardiology's 62nd Annual Scientific Session & Expo, which will be held at San Francisco, US from 9-11 March 2013.
