Thermedx LLC received U.S. Food & Drug Administration market clearance for its surgical fluid management system.
It’s the first market clearance for the Solon, Ohio-based company since opening for business in 2007.
The company’s 37-5 fluid management system enables users to manage and/or increase the temperature of up to five fluids used to irrigate surgical sites during urologic, gynecologic, orthopedic and general surgeries, according to a Thermedx release. Millions of Americans suffer hypothermia during surgery each year, the company said.
“Hospitals and ambulatory surgery centers are under increased pressure to reduce surgical costs and improve patient outcomes with effective irrigation fluid management playing a key role in such healthcare initiatives,” John Kurowski, the company’s vice president of sales and marketing, said in the release.
The multi-functional 37-5 Fluid Management System provides irrigation fluid management and warming in a single device, saving hospitals and ambulatory surgery centers capital dollars, Kurowski said.
Thermedx plans to follow the U.S. launch of its first product with a European launch in early 2011.