The European Commission has granted CE Mark approval to Blue Belt Technologies' Navio precision freehand sculpting (PFS) system.
Navio PFS integrates an intuitive surgical planning and navigation platform, providing surgeons with safety and enhanced accuracy while performing bone shaping tasks through less invasive incisions.
The company's initial market application in Europe is for Unicondylar knee replacement (UKR), intended to replace either the inside (medial) or outside (lateral) compartment of the knee with an implant.
The Navio PFS system employs patented technology to provide additional control to surgeons via an intelligent, handheld, cutting tool coupled with powerful surgical planning and navigation software. The navigation system camera overlooks the surgery and feeds information to update the visualisation that is presented to the surgeon.
The Navio PFS hand piece incorporates multiple intelligent control algorithms that enable the surgeon to precisely resurface bone based on a predefined plan.
Blue Belt Technologies Scientific Advisory Board co-chair Jess Lonner said the capacity for pairing conservative unicondylar bone preparation with a level of precision sets the Navio PFS system apart from conventional technologies and should contribute to functional recovery and durability.
Blue Belt Technologies president and CEO Eric Timko said the initial clearance of the system to use in UKR provides physicians with a robotic instrument for an accurate and consistent placement of the UKR implant.
"We are excited to begin executing on our commercialisation strategy in Europe and introducing the Navio PFS system to the physician community," Timko added.
The hand-held robotic device is not available for sale or distribution in the US.
Blue Belt Technologies is a medical device company focused on developing the next generation of smart surgical instruments providing precise robotic control for use initially in orthopaedic procedures and then for other surgical specialties, including neurosurgery, spinal and otolaryngology.