The FDA granted Intellirod De Novo approval for Loadpro, a disposable spinal rod strain sensor.
What you should know:
1. The Loadpro is a first-of-its-kind device. Surgeons use the device during kyphotic correction surgery to monitor for rod strain.
2. Surgeons can use the Loadpro with Xtant Medical's Fortex pedicle screw system.
3. Intellirod CEO Ric Navarro said, "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."
4. Intellirod will release the Loadpro at sites in Cleveland and Louisville, Ky. Intellirod plans to eventually expand its commercial launch and seek future pedicle screw system FDA approvals.