FDA Gives OK to Brainlab for Robotic Spine Procedures
February 23, 2021
Germany-based Brainlab has announced reaching two major milestones with the FDA clearance of its Loop-X Mobile Imaging Robot and Cirq, a robotic surgical system. Following on European CE mark approvals last summer, the FDA clearance allows Brainlab to enter U.S. markets with its Cirq robotic alignment module for spine procedures, and Loop-X, a robotic intraoperative imaging device.
Loop-X works with the full Brainlab digital surgery portfolio, or with a customer’s existing surgical setup, Brainlab said. Independently moving imaging source and detector panels enable flexible patient positioning, and non-isocentric imaging reduces the amount of radiation exposure to increase the variety of indications that can be treated. The Loop-X was developed in collaboration between Brainlab and medPhoton, based in Salzburg, Austria. The Hospital San Juan de Dios Leon in Spain recently performed the world’s first navigated spine surgery using Loop-X mobile imaging robot technology, the company said.
The new Cirq Robotic Alignment module (pictured, right) can fine-tune the alignment to a pre-planned trajectory to free up surgeons’ hands, enabling them to focus on the patient’s anatomy. Surgeons at Royal London Hospital in the U.K. have used Cirq for a range of cases, including routine lumbar fusions to more complex deformities and cervical fractures.
“We’re expanding and diversifying our digital surgery portfolio with robotics across all indications,” said Sean Clark, president of Brainlab. “Our customers want to offer their patients advanced technologies close to home. Brainlab technologies are designed to enable greater freedom for clinicians and enhance customer outcomes for patients.”
Founded in 1989, Brainlab is headquartered in Munich and employs more than 1,500 people in 20 offices around the world. The company serves physicians and medical professionals in more than 5,600 hospitals in 116 countries. MedPhoton develops and manufacturers robotic imaging solutions for image-guided radiation therapy and navigated surgery.
