Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning (RIC) at the point of care.
According to CellAegis, in the United States, there are an estimated 13.1 million annual incidences of myocardial infarctions, chest pain, cardiac revascularisation procedures and associated surgical procedures. Altogether, there are an estimated 23.4 million people in the U.S. living with prior heart attacks, angina and heart failure with an additional 57 million Americans are living with cardiovascular disease and have a 5-7 times greater risk than the general population of experiencing a myocardial infarction or death.
Cheery thought indeed. But having given us the dire stats the company helpfully provides a degree of optimism in the form of its so-called remote ischemic conditioning (hence the RIC) device. RIC apparently works by delivering sequences of short, controlled periods of reduced or no blood flow (ischemia) in a limb followed by resumed blood flow (reperfusion).
By activating innate mechanisms of metabolic protection in the body, this process seemingly conditions the heart and other organs against the most significant damage from ischemic reperfusion injury to cardiac and other organs, including myocardial infarctions, cardiac surgery, stroke, trauma, and organ transplantation.
The autoRIC Device is placed around the arm and allows for the first time, simple, consistent, reliable and cost-effective automation of RIC at the point of care, including acute care applications in the ambulance, emergency room and other hospital settings, or for chronic treatment in the home. The autoRIC Device is highly portable and time-efficient, delivering four cycles of simple-to-administer treatment in less than 40 minutes. The company says its device is compatible with current standard-of-care treatments.
Based on studies in over 10,000 individuals in more than 66 ongoing and completed clinical trials worldwide as well as key findings reported at medical conferences and published in leading peer-reviewed publications, data have reportedly shown that RIC can reduce heart damage by up to 40-50% in an evolving heart attack,(1) as well as improve left ventricular ejection fraction in left anterior descending coronary artery (LAD) infarction,(2) and is associated with reduced subsequent cardiovascular events late after percutaneous coronary interventions (PCI)(3) and most recently, reduced incidences of contrast-induced nephropathy.(4)
In the second half of this year, CellAegis is initiating an international trial of the autoRIC Device in the EU and U.S. in patients who will undergo elective PCI and cardiac surgery, including coronary artery bypass graft surgery. The randomised study will 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 U.S.
Rocky Ganske, CEO of CellAegis Devices, stated, “The CE Mark validates the safety of the autoRIC Device, and we are looking forward to starting a broad clinical testing program in the EU and United States later this year 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.”
The autoRIC Device is not yet cleared for sale in the U.S.
Source: CellAegis Inc., Business wire
1 Bøtker HE et al. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet 2010;375:727-34; DOI:10.1016/S0140-6736(09)62001-8
2 Munk K et al. Remote ischemic conditioning in patients with myocardial infarction treated with primary angioplasty: Impact on left ventricular function assessed by comprehensive echocardiography and gated single-photon emission CT. Circ Cardiovasc Imaging 2010;3:656-662; DOI:10.1161/CIRCIMAGING.110.957340
3 Hoole SP et al. Cardiac remote ischemic preconditioning in coronary stenting (CRISP Stent) study. Circulation 2009;119:820-827; DOI:10.1161/CIRCULATIONAHA.109.191747