Mainstay Medical applies for CE Mark: 5 key notes

Written by Laura Dyrda | November 02, 2015 | Print  |

Mainstay Medical applied for the CE Mark for ReActiv8.

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.


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