Here are five key notes on the patient:
1. The patient will participate in the trial after sustaining acute spinal cord injury. Treatment was at Carolinas Medical Center, which is part of Carolinas HealthCare System.
2. The co-principal investigators at the site are Dom Coric, MD, of Carolina Neurosurgery and Spine Associates and Chief of Neurosurgery at Carolinas Medical Center; and William Bockenek, MD, chief medical officer at Carolinas Rehabilitation.
3. Dr. Coric and his colleague Mark Smith, MD, performed the surgery to implant Neuro-Spinal Scaffold for the third time in a patient with acute spinal cord injury.
4. The surgery occurred three-and-a-half days after injury.
5. The Neuro-Spinal Scaffold is FDA-approved for the investigational device exemption pilot study for five subjects. Following the initial trial, InVivo plans to conduct a pivotal study for FDA approval before moving on to commercialization under a Humanitarian Device Exemption.
“The implantation procedure went smoothly and the patient is doing very well,” said Dr. Coric. “It has been rewarding to be involved in this clinical study, and I look forward to following the patient’s progress.”
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