Intellirod Spine received FDA de novo approval for the LoadPro, spinal rod strain sensor.
According to a company press release, the LoadPro clamps onto a 5.5-mm rod and is intended to be used in monitoring rod strain during kyphotic correction surgery. The FDA approval allows for use of the LoadPro with the Fortex pedicle screw from Xtant Medical. Intellirod reportedly plans to have site releases of the device in Louisville, Kentucky, and Cleveland.
“We are delighted to be the first device in this new FDA product category for spine to give the surgeon unprecedented new information about how much strain is on their rods as they correct a deformity,” Ric Navarro, CEO of Intellirod, said in the release. “Now the surgeon can quantify their tactile feel and be knowledgeable of the strain level as it relates to the yield limits of the rod material.”