Here are five takeaways:
1. The company established an Objective Performance Criterion in February, and a week later the study’s fifth patient experienced improvements from complete AIS A spinal cord injury to AIS B spinal cord injury.
2. Three of the five treated patients improved by at least one ASI grade six months post surgery.
3. InVivo only needs two more patients that experience improvement by at least one AIS grade to meet OPC requirements.
4. The FDA also accepted InVivo’s Humanitarian Devise Exemption modular shell and review process in March. The company hopes to submit the first module at the end of 2016.
5. Currently, 18 institutions serve as INSPIRE study clinical sites.
More articles on devices:
4 key notes on Smith & Nephew shares
Wenzel Spine announces limited release & first implantation of the next generation Varilift®-LX device
Dr. Kenneth Zaslav performs Virginia’s first meniscus replacement using NUsurface Implant — 4 highlights
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
