Velomedix has enrolled the first patient in a prospective, multi-centre clinical study of its rapid therapeutic hypothermia system for treating acute myocardial infarction (AMIs or heart attacks).
The Velomedix system circulates cold fluid in the peritoneal cavity, which is in contact with a large part of the body’s core and has 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.
During the company’s previous studies, patients treated with therapeutic hypothermia had ST segment elevation myocardial infarctions (STEMIs) of reduced severity, when cooled to temperatures of less than 35°C prior to percutaneous coronary intervention (PCI).
The trial, VELOCITY, will enrol 60 awake patients with anterior STEMIs from multiple US and Canadian sites 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, will be collected as part of several secondary endpoints.
Columbia University Medical Center / New York-Presbyterian Hospital cardiovascular research and education director and trial co-principal investigator Gregg Stones said; "Velomedix appears to have developed an ultrafast cooling technology that might be effective without significantly delaying reperfusion."