FDA grants breakthrough device status to SpinaFX Medical’s Triojection system
The U.S. Food and Drug Administration has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations, the Canadian company said on Wednesday.
The image-guided procedure uses a proprietary oxygen-ozone delivery system inserted into the spinal disc to reduce pressure and relieve nerve compression. The treatment can be performed on an outpatient basis in hospitals, ambulatory surgical centers, or clinics with minimal infrastructure, SpinaFX said.
The designation gives developers prioritized access to the FDA for feedback and review, aimed at accelerating regulatory clearance for devices addressing serious conditions.
SpinaFX said Triojection is intended as a targeted alternative to conservative care or invasive surgery, offering potential benefits in safety, recovery time and cost. The company added that international studies support the technology, with further trial results expected.
Posted by MedCloudInsider Editors on 08/20/2025