Velomedix, Inc. Receives Health Canada Approval for VELOCITY Pilot Study and Bolsters Leadership Team
1/9/2013 9:48:34 AM
MENLO PARK, Calif.--(BUSINESS WIRE)--Velomedix, a venture-backed medical device company advancing the field of therapeutic hypothermia, today announced it has received Health Canada Approval for its VELOCITY pilot study in addition to the previously announced US IDE approval. The study is a prospective, randomized, multi-center study designed to further evaluate the safety and feasibility of the Velomedix rapid therapeutic hypothermia system in patients with acute myocardial infarctions (AMIs or heart attacks). The study will enroll 60 awake patients with anterior ST segment elevation myocardial infarctions (STEMIs) at up to three Canadian sites in addition to US sites. Patients will be randomized to either primary percutaneous coronary intervention (PCI) or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.