InVivo Therapeutics enrolled the second patient in their Neuro-Spinal Scaffold to treat traumatic spinal cord injury.
The patient is enrolled at Carolinas Medical Center, part of the Carolinas HealthCare System in the study to evaluate the safety and feasibility of the Neuro-Spinal Scaffold.
Here are five things to know about the procedure:
1. Domagoj Coric, MD, chief of neurosurgery at Carolinas Medical Center, performed the procedure with John Ziewacz, MD. Both surgeons are part of the Carolina Neurosurgery and Spine Associates and Dr. Coric is a co-principal investigator at the site.
2. This is this second-ever spinal surgery performed using the Neuro-Spinal Scaffold to treat acute spinal cord injury. The patient sustained a severe multi-trauma injury requiring two days for medical stabilization before proceeding with the spine surgery and implantation.
3. The procedure took place as part of an investigational device exemption pilot study intended to capture preliminary data in five patients who have thoracic spinal cord injury. The company expects to conduct a pivotal study for FDA clearance following this trial.
4. Dr. Coric deemed the implantation procedure successful. This surgery came soon after InVivo Therapeutics re-opened their trial. The FDA only requires 30 days of safety day for this second surgery instead of the original 90 days before reopening enrollment.
5. If there aren’t significant safety issues, the company anticipates reopening the study for concurrent enrollment of three subjects in about two months.
Written by Laura Dyrda