Valorem Surgical’s Spinal Fixation System Gets FDA OK

Valorem Surgical on Tuesday announced the FDA clearance and first clinical use of its minimally invasive MaxiMIS spinal fixation system. The device stabilizes and immobilizes spinal segments during spinal fusion in skeletally mature patients.

The MaxiMIS will be available in limited markets through the end of the first quarter, with full U.S. launch to follow in the second quarter of 2015, the Chicago devicemaker said.

The low-profile, easy-to-use, percutaneous pedicle screw system, which can be used to treat a variety of spinal issues, was designed to reduce tissue disruption, blood loss and trauma, Valorem said. It is available in sizes from 4.0 x 25mm to 10.0 x 100mm and in monoaxial, polyaxial and cannulated versions.

Jae Lim, who performed the first surgery in Reston, Va., said the MaxiMIS provides intraoperative flexibility and its instruments work well with robotic guidance systems for MIS — Kellen Owings