The Cambridge, Mass.-based company’s neuro-spinal scaffold is designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The new patient was added at Charlotte, N.C.’s Carolinas Medical Center. Surgery was performed by Dr. Domagoj Coric and Dr. Samuel Chewning, both study investigators, approximately 19 hours after the injury ocurred.
“Implantation of the Neuro-Spinal Scaffold went smoothly and the patient is doing well. I have now implanted 5 patients with different injury types and locations, and the implantation procedure has been consistently uncomplicated. I look forward to following this most recent patient’s progress,” Dr. Coric said in prepared remarks.
“We now have 10 Inspire patients enrolled and in follow up, which is an important milestone in this study designed to enroll 20 evaluable patients. We thank Dr. Coric and his team for having enrolled 5 patients at their site, and look forward to continuing to make progress toward full enrollment,” CEO Mark Perrin said in a press release.
The company has added 1 new patient and 3 new sites to the trial over the past 2 months, at Pittsburgh, Penn.’s Allegheny General Hospital, Boston’s Beth Israel Deaconess Medical Center and at Alberta, Canada’s Foothills Medical Center.
The Cambridge, Mass.-based company said in August that the Inspire trial’s conversion rate for improvement in the American Spinal Injury Assn.’s 50-point lower extremity motor score is 62.5% – more than double the trial’s objective performance criterion of 25% at 6 months.
InVivo said that the trial’s 9th spinal cord injury patient, implanted with its neuro-spinal scaffold last month, is already showing signs of improvement. The device is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.
The trial’s 9th patient improved from a complete to incomplete spinal cord injury on the AIS scale between the 2nd and 3rd month after implantation; the patient is the 5th of 8 patients in the company’s Inspire study to show an AIS grade improvement, InVivo said.