Health Canada has approved Velomedix’s pilot study of its rapid therapeutic hypothermia system, designed for use in patients with acute myocardial infarctions (AMIs or heart attacks).
Utilising a peritoneal-based approach, the Velomedix system circulates cold fluid in the peritoneal cavity, which is in contact with a large part of the body’s core with a high percentage of blood flowing past it at any one time.
The system removes heat and cools patients to less than 35°C in fewer than 15 minutes, according to the venture-backed medical device company.
Previous studies conducted on hypothermia have shown that cooling can reduce the severity of ST segment elevation myocardial infarctions (STEMIs), only if patients are cooled to temperatures of less than 35°C prior to percutaneous coronary intervention (PCI).
The prospective, multi-centre study, named VELOCITY, will enrol 60 awake patients with anterior STEMIs and randomise them to receive either primary PCI or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.
The primary endpoint of the study is a composite of specific new-onset, serious adverse events during the first 30 days following treatment.
Infarct size, myocardial salvage, left ventricular volumes and left ventricular ejection fraction, assessed by cardiac magnetic resonance imaging (MRI), will be collected as part of several secondary endpoints.
Velomedix chief medical officer Dr Griff Tully said; "We are working with very experienced STEMI centers across Canada to obtain hospital approval and begin enrollment."