Thermedx, a maker of “smart” surgical irrigation products, has received 510(k) clearance from the Food and Drug Administration for a fluid warming product that it says could help reduce risk of hypothermia.
Physicians traditionally use cold surgical irrigation fluids in both inpatient and outpatient procedures, but Thermedx says the chilling liquids can triple the risk of surgical site infections and other such complications that can extend a patient’s hospital stay. By warming the fluids used to flush out wounds in surgery, for instance, the company’s new surgical irrigation device can help lower patient costs – and also improve the pace of wound healing.
This technology is already available for urologic procedures, but the Solon, Ohio company’s clearance allows optional fluid warming in arthroscopic and hysteroscopic procedures. It was initially cleared by the FDA in 2010, and has been on the market since early 2011.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Though many medical device makers manufacture surgical irrigation systems – including larger players like Stryker – Thermedx said in a release that it’s the only company with FDA clearance to provide optional fluid warming.
