Mainstay Medical’s implant for chronic back pain reveals positive results in clinical trial: 3 observations

Mainstay Medical, a Dublin, Ireland-based medical device company, released results from a clinical trial of its ReActiv8. The company hopes to gain CE Marking for its device, which is an implantable neurostimulation system intended for patients with chronic low back pain.

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The ReActiv8 trial involves patients with a mean age of 43.9 years and a history of low back pain. The patients previously received physical therapy and 70 percent took opioids for pain.

 

Here are three observations:

 

1. The new results from the trial indicate lasting improvement in pain, disability and quality of life.

 

2. At 90 days, 63 percent of subjects showed improvement in low back pain on the Numerical Rating Scale.

 

3. At 90 days, 57 percent of subjects demonstrated improvement on the Oswestry Disability Index, and 67 percent of subjects showed improvement on the EQ-5D scale.

 

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