Triojection® is indicated for herniated lumbar discs that compress or otherwise irritate the dura or exiting nerve root (as confirmed by patient history supported with MRI or radiographic findings), resulting in leg pain with or without back pain.
European Post Market Study
Minimus Spine is enrolling a post market study at select sites in Europe. The objective of this randomized study is to compare the outcomes and costs of Triojection and surgical discectomy. The study seeks to enroll approximately 50 patients. Several sites have been recruited and enrollment will started in July 2015. Additional information can be found at clinicaltrials.gov using this link. Contact us if you would like to be considered as a clinical site for this study.
US FDA Study
In the future, Minimus intends to conduct a pivtoal study for FDA approval. This study will likely include of 20-30 centers with collaboration between spine surgeons, interventional radiologists, pain management physicians and anesthesiologists. Contact us if you would like to be considered as a clinical site.