InVivo Therapeutics Holding Corp. recently showcased its Neuro-Spinal Scaffold, an investigational device, at the 83rd American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Washington, D.C. InVivo is involved in an ongoing Investigational Device Exemption (IDE) pilot trial of its Neuro-Spinal Scaffold in subjects with acute spinal cord injury.
At the event, members of InVivo’s management gave details on the intraoperative videos from the first two subjects enrolled in the trial thus far. In addition, intraoperative videos evaluating surgical implantation of the investigational Neuro-Spinal Scaffold in a porcine model of acute spinal cord injury at various early time points were presented.
Lorianne Masuoka, M.D., chief medical officer of InVivo Therapeutics told OTW, “The Neuro-Spinal Scaffold is designed to be placed inside a contusion cavity within the spinal cord to promote appositional healing which could spare white matter and promote healing, potentially enabling patients to regain lost neurologic function. In order to do this, a durotomy is performed followed by incision of the pia and myelotomy to obtain internal decompression. This procedure follows standard laminectomy, spinal realignment and whatever else is required per standard of care prior to placement of the investigational Neuro-Spinal Scaffold.”
Asked what surgeons at the meeting wanted to know, Dr. Masuoka noted, “The surgeons were most interested in seeing the operative videos demonstrating the reduction in internal cord pressure (despite external decompression laminectomy). They were particularly interested in the surgical technique for placing the Neuro-Spinal Scaffold into the contusion cavity (it was reassuring to note that in both cases in which this was placed into patients, the contusion cavity was present and easily accessed). All of the surgeons wanted detailed information about the neurologic status of the study patients that have received the investigational Neuro-Spinal Scaffold and were not surprised that there were no safety issues associated with the product (‘the scaffold is the least of the concerns’). They were eager to learn about future potential studies such as patients with non-thoracic injuries.”
