The FDA has cleared two Brainlab AG surgical robots: the Loop-X Mobile Imaging Robot and the Cirq Robotic Alignment Module, a robotic surgical system for spine procedures. The clearances follow CE mark approvals last summer.
Claiming the “first fully robotic intraoperative imaging device on the market,” the company said the Loop-X’s independently moving imaging source and detector panels, “enable flexible patient positioning and non-isocentric imaging which reduces the amount of radiation exposure and increases the variety of indications which can be treated.” The mobile imaging robot can be controlled wirelessly with a touchscreen tablet.
The Cirq Robotic Alignment Module, according to December 2020 FDA clearance documents, is intended to be an intraoperative image guided localization system “to support the surgeon to achieve pre-planned trajectories with surgical instruments.” The indications for use of the CIRQ module for spinal use “is the treatment of diseases where the placement of spinal screws is indicated.”
The company says the module is capable of “fine tuning the alignment to a pre-planned trajectory and freeing up surgeons’ hands, enabling them to focus on the patient’s anatomy.” The module has already been used by surgeons at Royal London Hospital for cases ranging from lumbar fusions to complex deformity and cervical fractures.
According to the FDA documents, the module is connected to the Surgical BaseSystem from Germany-based Medineering GmbH and aligns instruments to a pre-planned trajectory during surgical procedures using the Cirq Robotic Application Software together with the Brainlab IGS Spinal software applications.
Infrared passive marker-based tracking provided by the optical tracking camera unit of the navigation platform is used to determine the instrument’s and patient’s position. The relation between the patient and the reference attached to the patient is realized with a manual or automatic registration (manually or automatically).
The device is manually pre-aligned to the region of interest by opening the brakes of the Surgical Base System using its “7 degrees of freedom.” The tracking information is used to automatically fine align a tracked guide attached to the Cirq Robotic Alignment Module to “achieve a pre-planned trajectory” controlled by the application software. After finishing the alignment, the device remains in this position and the surgeon “can use surgical instruments through the provided guide to perform the surgical steps intended without losing the trajectory.”
Brainlab was founded in 1989, employs more than 1,500 people in 20 offices and is present in over 5,600 hospitals in 116 countries.