FDA grants breakthrough device designation to SpinaFX’s Triojection system

The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations.

Triojection is an image-guided procedure that uses a proprietary oxygen-ozone delivery system to treat the affected spinal disc. During the procedure, clinicians insert a specialized syringe cartridge into the disc under image guidance. The system delivers a controlled mixture of oxygen and ozone, which reduces the pressure inside the disc and alleviates compression on nearby nerves.

SpinaFX designed the approach to precisely target the herniated area without damaging surrounding tissue. It can be performed on an outpatient basis in hospitals, ambulatory surgical centers, or clinics with minimal infrastructure requirements, making it suitable for both advanced and resource-limited healthcare settings.

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