Is InVivo & #039;s Neuro-Spinal Scaffold Back on Track After Halted Trial?

InVivo Therapeutics appears to be back on track with its Neuro-Spinal Scaffold, after pausing enrollment in its INSPIRE study last year due to three patients who had received the implant died.  The Cambridge, MA-based company presented six-month primary endpoint results from the single-arm study this week at the American Association of Neurological Surgeons meeting. FDA also gave InVivo the green light recently for a randomized, controlled study of the device that will include 20 patients. In July, InVivo halted enrollment in the INSPIRE study following the third patient death. Although the deaths were not believed to be related to the device, the company wanted to talk to FDA about the cases to ensure that each of the three patients who died had been comprehensively evaluated and that all appropriate risk mitigation measures had been implemented. It was during those discussions that InVivo proposed a randomized controlled trial to supplement the INSPIRE data, rather than reopening the INSPIRE trial, which enrolled a total of 19 patients. Of the 16 evaluable INSPIRE patients, seven patients (44%) improved from baseline on the American Spinal Injury Association (ASIA) impairment scale at six months. The study objective was a 25% improvement rate on the ASIA scale, based on the published data for thoracic spinal cord injury. InVivo also encountered quite a bit of distraction over the past 15 months as it dealt with a bizarre takeover bid from former CEO Frank Reynolds, the c...
Source: MDDI - Category: Medical Devices Authors: Tags: R & D Implants Source Type: news