Velomedix, Inc., a venture-backed medical device company advancing the field of therapeutic hypothermia, announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to expand the design of its VELOCITY pilot clinical trial. This North American trial will evaluate the use of rapid therapeutic hypothermia in the treatment of patients suffering an acute myocardial infarction (AMI or heart attack). Positive discussions with the FDA resulted in approval to include a control arm for a randomized comparison, thus doubling the number of patients, and to increase the number of U.S. trial sites.
Mild therapeutic hypothermia has been shown to substantially improve outcomes for acute events, such as heart attack and cardiac arrest*. While several technologies are currently being used clinically for hypothermia management, Velomedix's proprietary technology delivers unparalleled cooling speed, as demonstrated in previous clinical trials*. This form of rapid cooling may enhance clinical outcomes and enable widespread clinical adoption of this promising therapy. "More rapid cooling may be critical to reduce infarct size in patients with heart attacks undergoing angioplasty," commented Gregg Stone, MD, Columbia University Medical Center / New York-Presbyterian Hospital and co-principal investigator of the VELOCITY trial.