Here are five insights:
1. The amended protocol enforced the Objective Performance Criterion for The INSPIRE Study: InVivo Study of Probably Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury.
2. An OPC measures the safety and benefit of a device for a Humanitarian Device Exemption approval.
3. The established OPC for The INSPIRE Study outlines that 25 percent or more patients see an improvement of at least one ASIA Impairment Scale grade by six months post-implantation.
4. HDE approval is not certain, even if an OPC is met.
5. “The OPC provides additional clarity regarding our path to commercialization,” said Mark Perrin, InVivo’s chairman and CEO.
More articles on devices:
Surface Dynamics validates Evonik’s PEEK polymer for titanium coating — 5 observations
RTI Surgical names 2 new board members: 6 things to know
Medtronic, Wright Medical, RTI Surgical & more: 17 key notes
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
