FDA approves Velomedix’s IDE to expand design of VELOCITY trial for heart attack
Published on November 29, 2012 at 1:54 AM
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.
The VELOCITY trial is a 60-patient randomized trial at up to nine U.S. investigational sites to evaluate the Velomedix Automated Peritoneal Lavage System in patients with ST segment elevation myocardial infarction, presenting within six hours of symptom onset. The study will investigate the safety and feasibility of augmenting today's standard of care (primary PCI) with mild therapeutic hypothermia delivered by the Velomedix system. "We are very excited that collaboration with the FDA resulted in a randomized trial which will likely provide much more clinically useful information than a comparison to historical control," said Jeff Gold, President and CEO of Velomedix.
The study's primary endpoint is a composite of specific new-onset, serious adverse events during the first thirty days following treatment. Several secondary endpoints will also be collected, including infarct size, myocardial salvage, and left ventricular ejection fraction. Thus, while primarily a safety trial, it will also gather meaningful efficacy information.