February 16, 2012 — Velomedix Inc., a clinical stage medical device company, received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate the use of rapid therapeutic hypothermia for the treatment of patients suffering an acute myocardial infarction (AMI or heart attack). The conditional approval allows the company to initiate a clinical trial at select sites in the United States.
Therapeutic hypothermia has been shown to significantly improve outcomes for several acute events such as cardiac arrest, heart attack, and acute ischemic stroke. It has also been used with great success for spinal cord injury. While there are several technologies currently being marketed for hypothermia management, Velomedix’s proprietary technology delivers unparalleled cooling speed and procedural efficiency that is expected to result in enhanced clinical outcomes and enable more widespread clinical adoption of the therapy. “While current technologies can reach a therapeutic target temperature of 33 C in one to two hours, the Velomedix system has shown the ability to achieve 33 C in less than 15 minutes,” commented Jeff Gold, president and CEO of Velomedix.
“For AMI patients requiring an intervention to open a blocked artery, the ability to deliver rapid cooling is crucial to optimizing the protective benefits of therapeutic hypothermia while still complying with mandated hospital ‘time-to-treatment’ standards,” added Griff Tully, M.D., Velomedix’s vice-president and chief medical officer.
The recently approved IDE study will build upon limited, yet significant, data developed over the last eight years for the use of therapeutic hypothermia for heart attack victims. Though the early randomized studies clearly pointed to the potential benefits of therapeutic hypothermia in this patient population, the effectiveness of the therapy was limited by the slow cooling times of the technologies employed and, as such, failed to meet the primary clinical endpoints. More recent studies have shown that rapid cooling, as enabled by Velomedix’s proprietary system, can result in clinical results that rival the best data extracted from earlier studies. Study patients who were rapidly and effectively treated with therapeutic hypothermia showed up to a 50 percent reduction in the amount of heart muscle lost during a major heart attack. This reduction is expected to correlate with improved survival rates and enhanced quality of life post-infarct.
It is anticipated the Velomedix IDE study will begin enrolling patients in the second half of 2012.
For more information: www.velomedix.com