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www.fdanews.com/articles/167849-first-patient-implanted-with-invivos-spinal-scaffold

First Patient Implanted With InVivo’s Spinal Scaffold

October 15, 2014

InVivo Therapeutics said Tuesday it has enrolled the first patient in a pilot study of the Neuro-Spinal Scaffold. The device is being evaluated as a treatment for complete traumatic spinal cord injuries.

The study — conducted at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz. — will gauge the safety and preliminary efficacy of the scaffold, determined by no worsening of paralysis or sensory motor neurological function, the company said.

Principal investigator Nicholas Theodore, who performed the procedure, said it went smoothly and the patient is doing well.

As part of its investigational device exemption, InVivo agreed not to enroll additional studies until the initial patient was three months post-surgery. The company hopes to eventually enroll four more patients and wrap the study up in February 2016.

InVivo CEO Mark Perrin called the trial the first step in meeting a huge unmet medical need in spinal cord injury treatments. — Kellen Owings

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