Brainlab announced today that the FDA granted 510(k) clearance for its Spine Mixed Reality Navigation platform.
The advanced surgical navigation platform equips users with mixed reality to support to deliver an ergonomic view of the navigation screen. It allows surgeons to place pedicle screws with the vital information directly in their field of view.
With FDA clearance, the company said it began its U.S. launch for the solution marking a milestone in the advancement of spinal surgery.
Spine Mixed Reality Navigation combines the Chicago-based company’s optical navigation system with mixed reality. It delivers extended visualization projected directly in the sterile field to provide a layer of confidence one step beyond traditional offerings. Real-time visualization of entry and target points enables the desired placement of pedicle screws according to surgeon’s plans. Brainlab said this includes minimally invasive surgery cases where target identification remains a challenge.
Dr. Jason Pittman of Beth Israel Deaconess Medical Center in Boston provided feedback throughout the navigation platform’s development. Pittman said the system provides “clear value… with the enhanced visualization, accuracy and trueness.”
“We’re ushering in the future of spine surgery, putting groundbreaking tools in the hands of U.S. surgeons. European surgeons are already experiencing the power to see, critically observe and optimize clinical procedures with Spine Mixed Reality Navigation. This solution delivers hyper realistic 3D visuals and extended visualization, while the workflow, instruments and navigation provide familiar and expected precision. Together with our customers, we’re driving accuracy in the O.R.,” said Sean Clark, president, Brainlab.
