Blue Belt Technologies, a medical device manufacturer based in Pittsburgh, Pennsylvania, received clearance from the United States Food and Drug Administration for its NavioPFS Surgical System. The NavioPFS is a robot-assisted surgery tool for partial knee replacement.
According to a press release by the company, the NavioPFS orthopedic surgery system is cleared for partial knee replacement. Manual surgical instruments are commonly used in this type of procedure.
The company plans to launch sales of the product in the U.S. market immediately. The company states that it will continue to develop other applications for the surgical system. The device uses both intra-operative navigation and 3D visualization to guide handheld instruments. These tools help a surgeon during a knee surgery bone resurfacing procedure.
In prepared remarks, CEO and president Eric Timko said, "The entire Blue Belt team, including our physician advisors, has remained committed to providing orthopedic surgeons and hospitals a more precise and consistent technique to perform UKR procedures that takes into consideration the current economic environment in our healthcare system.” He continued, "We are confident that NavioPFS accomplishes these goals, and provides excellent results for patients."
The assistive surgery system was granted CE Mark approval by the European Union in February of this year. The system has also produced excellent clinical results in U.K. and Belgium trials. The company’s competitors include Intuitive Surgical and Mako Surgical.