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# IDE Approval Given to InVivo Therapeutics Spine Scaffold
- URL: https://www.fdaweb.com/ide-approval-given-to-invivo-therapeutics-spine-scaffold/
- Published: 2018-03-08T12:00:00.000Z
- Updated: 2026-09-14T23:28:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140935

FDA has given IDE approval to InVivo Therapeutics Holdings for a second pivotal clinical study involving the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury. The 20-patient, randomized, controlled trial is designed to complement existing clinical evidence from the company’s single-arm INSPIRE study. In the new trial, study success is defined as 20% or more scaffold-arm subjects who demonstrate an improvement of at least one grade on the American *Spinal*Injury Association Impairment *Scale (AIS)* at the six-month primary endpoint follow-up visit versus comparator-arm subjects. The company recently reported that seven of 16 (43.8%) evaluable patients in the INSPIRE study experienced an improvement in AIS grade from baseline at six months. Data from the studies is expected to support a potential Humanitarian Device Exemption submission to FDA, the company says.