Velomedix has obtained regulatory approval from Health Canada for its pilot study of Velomedix rapid therapeutic hypothermia system, designed for use in patients with acute myocardial infarctions (AMIs or heart attacks).
The Velomedix system , which incorporates a peritoneal-based approach, circulates cold fluid in the peritoneal cavity, which is supposed to be in contact with a large part of the body’s core and a high percentage of blood passes past it at any one time.
The system removes heat and cools patients to less than 35 degrees C in fewer than 15 minutes, according to Velomedix
The prospective, multi-center study, named VELOCITY, will enroll 60 awake patients with anterior STEMIs and randomize 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 thirty 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 the several secondary endpoints.
Velomedix chief medical officer Griff Tully said, "We are working with very experienced STEMI centers across Canada to obtain hospital approval and begin enrollment."