The Cambridge, Mass.-based company said that the Contempo study looks to provide comprehensive natural history benchmarks for the Inspire study of its Neuro-Spinal Scaffold, an implant designed to act as a physical substrate for nerve sprouting after acute spinal cord injuries.
The NACTN registry is derived from a network of academic neurosurigcal departments and hospitals with a focus on spinal cord injuries, especially acute injuries, the company said. The registry includes acute patient data, including pre and post-operative data, post-injury complications and treatments, MRI data and follow-up neurological exam data.
“The NACTN Registry was developed in large part to aid in the interpretation of SCI clinical trial results. This is the first time that the registry will be used with a partner in industry, and I believe that the registry will provide a valuable benchmark for analysis of Inspire results,” Contempo Registry principal investigator & InVivo scientific advisory board member Dr. James Guest said in a prepared statement.
InVivo said that Contempo registry study and Inspire study data will provide appropriate evidence for the safety and probable benefit required by Humanitarian Device Exemption approval process, with results slated to be submitted to support HDE approval.
“We are grateful for the care and vigilance that NACTN has put into developing an impressively thorough, curated database over many years. The inclusion of the NACTN Registry substantially increases the strength of the Contempo registry study. We look forward to completing the Inspire study and the Contempo registry study and submitting the results together in 2018 in an application for HDE approval of the Neuro-Spinal Scaffold,” CEO Mark Perrin said in a press release.
The post InVivo adds Reeve Foundation database to Contempo registry study appeared first on MassDevice.
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