SpinaFX Medical earned the FDA’s investigational device exemption for Triojection, an intradiscal ozone/oxygen injection, according to a June 9 news release.
Triojection will be evaluated in a U.S. clinical trial comparing it and nerve root block with nerve root block alone to address contained herniated lumbar discs. The planned study is expected to enroll 300 patients who previously failed conservative therapy.
“While this approach has been used in certain markets outside the United States, the U.S. pivotal trial is intended to evaluate its safety and effectiveness in a rigorous clinical setting and to help determine whether it may become an additional minimally invasive option for appropriately selected patients in the U.S.,” Dr. Kieran Murphy, CMO of SpinaFX, said in the release.
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