OBP Medical Announces ONETRAC Regulatory Clearance in Brazil
OBP Medical, a leading global developer of single-use, self-contained, illuminating medical devices, today announced regulatory approval from Brazil’s National Health Surveillance Agency (or Agência Nacional de Vigilância Sanitária (ANVISA)) to market ONETRAC®. The first single-use, cordless surgical retractor with integrated LED light source and smoke evacuation channel, ONETRAC provides optimal access, illumination and exposure of a tissue pocket or cavity during surgical procedures and reduces the unnecessary risk of cross-contamination often associated with reusable products. ONETRAC is available immediately through OBP Medical’s distribution partners in Brazil.
“ONETRAC combines ease of use, strong tissue grip and unparalleled visualization in a single device, making it ideal for a wide range of surgeries, including cosmetic and reconstructive procedures,” said Jason Swift, CEO of OBP Medical. “As the world’s second largest plastic surgery market after the United States, Brazil represents an important new region for ONETRAC and we are excited to work with local partners to meet the strong demand from Brazilian surgeons for safer and more effective surgical pocket illumination.”
Most surgical retractors—used to separate and/or hold back soft tissue and allow unobstructed access to a surgical site—are comprised of a reusable stainless-steel retractor and a fiber optic cord that connects the device to an external light source. Fiber optic retractors have been associated with patient injury, including burns. In addition, healthcare organizations currently clean, sterilize and reuse retractors and fiber-optic cords after each procedure. Beyond the high cost and complexity associated with device maintenance and reprocessing, a growing body of evidence suggests that even when healthcare professionals follow rigorous cleaning and disinfection protocols, the risk of cross-contamination and infection from improperly cleaned reusable parts remains.
ONETRAC sets a new standard for safe, easy-to-use surgical retractors by combining light and device. A fully integrated and cordless system, ONETRAC comes out of the package ready for use—no additional parts, assembly or fiber-optic cables required—and is disposed of in its entirety after a single procedure. As a result, ONETRAC eliminates the need for reprocessing and reduces the risk of cross-contamination.
About OBP Medical
OBP Medical is the leading global developer of single-use, self-contained, illuminating medical devices. We create simple and effective single-use solutions by integrating medical devices with LED light sources, making them one. At OBP Medical, we illuminate the everyday.Our innovative products are in use at more than 6,000 physician offices, surgery centers and hospitals throughout the U.S., as well as healthcare facilities worldwide.For more information about OBP Medical and our line of self-illuminated medical devices, please visit www.obpmedical.com, check out our Simple.Bright.Ideas.BLOG or follow us on Twitter. OBP Medical is proud to be ISO13485 certified.