InVivo Therapeutics temporarily halts INSPIRE enrollment after patient death
The most recent patient to enroll into the INSPIRE study, who was implanted in late June, passed away suddenly at a rehabilitation facility following discharge from the hospital. The cause of death was deemed by the Principal Investigator at the site to be unrelated to the Neuro-Spinal Scaffold or implantation procedure. This represents the third death in INSPIRE to date, all of which have been deemed to be unrelated to the investigational product or implantation procedure by each respective site's Principal Investigators. The company has elected, based in part on discussions with the company's independent Data Safety Monitoring Board, to implement a temporary halt to enrollment as it engages with the Food and Drug Administration to determine whether any changes to patient enrollment criteria related to patients who may have a higher mortality risk or other study modifications are deemed necessary. As a result of the temporary enrollment halt, the company anticipates completing INSPIRE enrollment in the first half of 2018 and submitting a Humanitarian Device Exemption application in the second half of 2018.