Kevin Lester, M.D., of Community Regional Medical Center, Fresno, California, has performed the first three Navio PFS unicondylar knee replacement (UKR) surgeries in the U.S. on patients suffering from medial osteoarthritis. Blue Belt Technologies, Inc, of Pittsburgh, Pennsylvania, received 510(k) clearance to market the NavioPFS system in the United States at the end of November 2012. The company defines its NavioPFS System as the next generation of “smart” surgical instruments that provide precise robotic control to surgeons via an intelligent, handheld, computer-assisted bone-cutting tool.
According to the manufacturer, The NavioPFS surgical system represents the next generation of precision orthopedic surgery, with an initial indication for use in UKR procedures. “Performing three surgeries out of the gate in the United States is a significant milestone for us and confirms that Dr. Lester and Community Regional will be excellent partners for us and our technology moving forward, ” said Eric B. Timko, president and CEO of Blue Belt Technologies. “We are all very pleased with the initial results and look forward to continued success as we begin our commercialization, both in the U.S. and European markets.”
Lester successfully planned two left-medial and one right-medial partial knee replacement surgeries and executed bone preparation through what Blue Belt officials described as a less-invasive incision using the NavioPFS precision freehand sculpting hand piece.
“The NavioPFS system worked perfectly, allowing me to plan my surgery exactly as I wished, and executing that plan precisely as intended, ” Lester said. “In partial knee replacements, maintaining the integrity and balance of the soft-tissue envelope is a difficult variable to properly control when using manual instrumentation. Using the NavioPFS, this step is seamlessly integrated into the system, and the robotic hand piece allows for precise and repeatable bone preparation.”
