When a medical device company is working in the same market space as players like Stryker and Olympus, securing U.S. Food and Drug Administration clearance is only half the battle. Solon, Ohio-based medical device company Thermedx has the FDA clearance in place as well as several local customers and is now embarking on the mission of establishing a presence outside of its home state. Thermedx makes a fluid management system to help surgeons avoid complications associated with irrigation fluids, which are used in millions of gynecology, urology, orthopedic and other surgeries every year to distend body cavities or clear away blood and debris. A gynecology surgeon, for example, may distend a woman’s uterine cavity during a hysteroscopy to improve his ability to see during the procedure. But to prevent perioperative hypothermia, the liquid used for distention would traditionally be heated in some kind of warming device before being delivered. This device combines that step and others to streamline the process. “This is the only FDA-cleared device that can pressurize, warm, deliver and measure the irrigation fluid in one device,” said Executive Vice President Mike Haritakis. Cleared by the FDA in 2010, the device hit the market in early 2011 and has since made its way into some of Northeast Ohio’s big hospital chains. Although its primary target market is gynecology, it’s also used in some urology and orthopedic procedures.
