ZimVie, Brainlab collab bears fruit with FDA nod for combined spinal fixation system

Less than a year after ZimVie tapped Brainlab to add its surgical guidance technology to ZimVie’s own spinal surgery devices, the partnership has already paid off.

The first product of their collaboration, combining Brainlab’s Spine & Trauma Navigation software with ZimVie’s Vital spinal fixation system, has now received FDA clearance, the duo announced Tuesday.

The Vital system is designed to be used in degenerative thoracolumbar procedures, in which multiple vertebrae are connected to one another to reduce potentially damaging movements along the spinal cord. ZimVie’s kit includes all the instruments and implanted screws needed to conduct a spinal fixation procedure.

Brainlab’s spinal surgery navigation technology, meanwhile, provides digital guidance throughout a procedure, automatically integrating into a facility’s existing imaging technology. Brainlab has also positioned its platform as a way to reduce radiation exposure, since it’s designed to improve surgeons’ precision, therefore requiring fewer X-rays to double-check the placement of instruments and implants.

With the regulatory clearance in hand, ZimVie will now market the Brainlab software alongside the Vital system in the U.S., with their commercial launch expected to begin early next year.

“This is a positive milestone for both teams and the first of what we hope will be many FDA clearances for compatibility. The strong collaboration between our organizations resulted in an expedited project timeline,” Rebecca Whitney, global president of ZimVie Spine, said in the announcement.

Their next target for joint FDA clearance will combine Brainlab’s navigation platform with ZimVie’s Virage system, another set of tools for spinal fixation procedures that focuses on occipital-cervico-thoracic (OCT) indications, in the upper regions of the spine, compared to the lower, thoracolumbar focus of the Vital system.

ZimVie is planning to submit the Virage system for FDA clearance next year, per this week’s release.

ZimVie and Brainlab pulled back the curtain on their partnership in March of this year, with plans to integrate their respective spine surgery-focused offerings. Not long after, this summer, they expanded the terms of their deal to allow ZimVie to co-market Brainlab’s tech alongside its own surgical tools.

The Zimmer Biomet spinout had been on the hunt since its early 2022 formation for a partner with existing technology that could add to its own to create a comprehensive spinal surgery system—as opposed to building the entire system itself.

It selected Brainlab as that partner. In addition to its surgical planning and navigation software, which incorporates artificial intelligence, mixed reality and other high-tech tools, Brainlab has also developed a range of surgical hardware, including automated robotic systems to aid in imaging and offer physical assistance during procedures.