Dive Brief:
- Zimvie secured 510(k) clearance for its Vital Spinal Fixation System and instruments for use with Brainlab’s Spine & Trauma navigation software, positioning the company to co-market the products early next year.
- Brainlab and Zimvie began working to integrate their technologies in March. At the time, Zimvie framed the arrangement as a way to improve operating room workflows and accuracy and reduce radiation exposure.
- Zimvie is looking to the integration to add to its struggling U.S. spine unit, which reported a nearly 10% drop in sales in the third quarter amid competitive pressures in core spine.
Dive Insight:
Brainlab provides software that is designed to enable accurate placement of devices used in spinal fusion procedures. The company pitches the software as a way to place screws more accurately, reduce the need for verification scans and, by extension, reduce exposure to X-ray for the patient and surgical team.
In March, Zimvie disclosed a collaboration with Brainlab to achieve compatibility between its Vital and Virage fixation systems and its partner’s spine and trauma navigation technologies. The companies expanded the agreement to include co-marketing in August.
The collaboration passed a milestone this week when the Food and Drug Administration cleared Zimvie’s Vital Spinal Fixation System including instruments for use with Brainlab’s navigation software. Zimvie plans to bring the first Vital sets to the U.S. market early next year. A 510(k) filing for the other Zimvie fixation system covered by the collaboration, Virage, is planned for next year.
Zimvie has identified the Brainlab partnership as one way to add to its spine business. Talking to investors in August, Zimvie CEO Vafa Jamali said “we really decided that we had to invest more seriously, more heavily in our platforms,” adding that the company was addressing “the areas of concern.”
“With Brainlab, I think we’re really secure in a good place there with a very, very state-of-the-art technology platform added to our devices, which I think are going to be a really, really great match,” the CEO said.