Health Canada has granted marketing authorisation to CellAegis Devices’ autoRIC device for remote ischemic conditioning (RIC).
Health Canada’s Medical Device Class III licence 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 proprietary, automated, noninvasive device, which is placed around the arm, is compatible with current standard-of-care treatments and delivers four cycles of easy-to-administer therapy in less than 40 minutes, according to the company.
Intended for use in a hospital, ambulance or home, as directed by a healthcare professional, the portable device also offers a safe and accurate method of automating RIC at the point of care.
The Hospital for Sick Children cardiology head Dr Andrew Redington and University of Toronto cardiac surgery division chair and professor Dr Christopher Caldarone said in a joint statement that RIC activates innate mechanisms of metabolic protection, and has the potential to revolutionise 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 said.
The company said it is planning to start marketing the device in Canada in the second half of 2013, and is planning to incorporate the autoRIC Device in multiple clinical trials throughout the global cardiology community.
CellAegis Devices CEO Rocky Ganske said; "We believe these trials will help augment the growing body of evidence in support of RIC for diverse applications in cardiovascular disease."