The FDA met with the company in early June to discuss its pilot study and found the results “achieved its objectives of feasibility, safety and rapid cooling, while showing a very strong trend for brain protection and better recovery,” Life Recovery Systems said in a June 16 news release.
The ThermoSuits apply water to the skin to rapidly lower core body temperature and usually cool to the target temperature in 40 minutes or less, the release said. Laboratory studies have indicated rapid cooling techniques could reduce brain injuries in acute ischemic strokes, of which there are about 800,000 recorded every year in the U.S.
If the prospective study meets its endpoints, the product could improve patient outcomes and lower treatment costs, Life Recovery Systems said.
