An important breakthrough in the management of lower back pain occurred with the arrival of Mainstay Medical’s implant treatment to the US market. The medical organization has succeeded in formulating an implanted therapy for individuals who have back problems such as chronic lower back pain.
A trial is being conducted at the moment with the aim of getting FDA approval. As a part of the trail, several patients are being treated by implanting Mainstay’s latest device named Reactive 8 into their bodies.
Due to extensive lower back pain, the patient suffers from pain and inflammation in the lower back area. The decrease in the spaces between the vertebral discs and pinching of the intervertebral disk in the lower back leads to this pain.
Functioning of Reactiv8
The functioning dynamics of Reactive 8 involve stimulation of nerve cells in the lower back area, especially the nerve root that is affected, to subsequently strengthen the muscles in the area.
- The treatment has been tested on about 58 people so far
- The results have been nothing short of successful
- None of the patients faced any side effects
- Nor were there any safety concerns to be found
Reactive8 is currently being used in Ireland and Germany, as the regulatory authorities of the regions have allowed the sale of this device. To increase and influence the US market, the company is taking help from Mr. Hannon, President at NuVasive.
NuVasive has been operating in the US for some time now and is focused on finding minimally invasive ways of combating spinal pains and injuries. Mainstay is using his influence and intellect to commercialize their product in the states.
Mr. Hannon said that once the release of the product is made official, the company will allocate reimbursements to train the medical practitioners about the usage of this new treatment. He further said that there are many sites in Switzerland, UK and Australia that are busy in enrolling patients for the trials.
Trials in the US
Along with this, Mainstay is also expected to invest in the US market to create a larger scope for Reactive8. The company already has $12.7 million at their disposal and more fundraising for the project is to be done.
It is expected that by mid-2018, the company will have enrolments to carry out the trails and hopefully, by the end of the year, they will be able to present the final data relating to the testing of this treatment. Once the trials are successful, pain management in Phoenix and other parts of the country will be much simpler and easier.
- The committee has advised the enrolment of 168 people.
- 133 people have already been enrolled.
- Others are expected to come by next year.
These trial subjects are to be analyzed for four months after the implantation of Reactive8 and the effect of the device is to be observed in the patients to determine the effectiveness of this technique in pain management.