InVivo temporarily halts Inspire study enrollment after patient death

InVivo Therapeutics (NSDQ:NVIV) said today it is temporarily suspending enrollment in its Inspire trial of its neuro-spinal scaffold after its most recent patient, implanted last month, passed away suddenly following hospital discharge. While the death was deemed to be unrelated to the neuro-spinal scaffold or the implantation procedure, the company said it was initiating a temporary enrollment halt while it discusses possible patient enrollment criteria changes with the FDA. Due to the enrollment halt, Cambridge, Mass.-based InVivo said it expects it will complete enrollment for the trial during the 1st half of 2018, with a slated submission seeking humanitarian device exemption from the FDA during the 2nd half of 2018. “Our thoughts and condolences are with the patient’s loved ones at this difficult time. We remain committed to monitoring carefully all aspects of the Inspire study to ensure the ongoing safety of subjects. Regarding the enrollment halt, we are working toward an expeditious resolution. Based on the compelling clinical results to date, particularly the 2 most recent AIS conversions, we hope to reopen enrollment as soon as possible,” CEO Mark Perrin said in a press release. The company’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. InVivo updated on patient conversions within the trial, saying that 1 patient had...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Neurological Spinal Source Type: news