Here are five key notes:
1. ReActiv8 is an implantable neurostimulation system for patients with chronic low back pain.
2. The application brings Mainstay Medical a step closer toward commercialization in Europe.
3. The application includes a clinical trial showing the statistically significant pain, disability and quality of life improvement for chronic low back pain patients with limited treatment options that use ReActiv8. There is also lasting improvement data.
4. Mainstay Medical also has FDA approval to begin the ReActiv8-B clinical trial to gather data for approval in the United States.
5. The company plans to establish a direct sales force for ReActiv8 commercialization in key European markets starting next year, pending CE approval.
More articles on orthopedic devices:
Stryker, Smith & Nephew, Zimmer Biomet & more: 16 key notes
Miliman report analyzes procedures for lumbar spinal stenosis
OrthoGrid creates new total hip replacement guide for HipGrid line
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.
