The U.S. robot-assisted surgery space added a new player this week with FDA clearance for Blue Belt Technologies’ NavioPFS orthopedic surgery system.
The Pittsburgh, Pa.-based device maker won clearance with indication for partial knee replacement, a procedure generally performed using manual instruments, the company noted.
Blue Belt plans to launch U.S. sales right away for partial knee replacement and to continue development in other applications for NavioPFS.
The device uses 3D visualization and intra-operative navigation to guide hand-held instruments, helping a physician precisely resurface bone during knee surgery.
"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," president & CEO Eric Timko said in prepared remarks. " We are confident that NavioPFS accomplishes these goals, and provides excellent results for patients."
The system won CE Mark approval in the European Union in February 2012, and the NavioPFS has produced "excellent early clinical results" in trials in Belgium and the U.K., Blue Belt noted.
The company enters a U.S. robot-assisted surgery market with few direct competitors, Mako Surgical (NSDQ:MAKO) being the primary rival in the orthopedic world. Arena heavyweight Intuitive Surgical (NSDQ:ISRG) and its da Vinci system own significant share in prostatectomy and hysterectomy procedures, but Mako is the only other company with an FDA-cleared robot-assisted device in orthopedics.
Mako, which recently closed a $40 million fundraising round with an extra $3 million in tow, has struggled to keep its procedure volumes at expectations. The company reported losses of $6.6 million, or 15¢ per share, on sales of $29.2 million during the 3 months ended Sept. 30, 2012.