Stimulation at the Surface

The market for surface stimulation systems took a major hit in 2012 when the Centers for Medicare and Medicaid Services decided to remove reimbursement for transcutaneous electrical nerve stimulation systems as a treatment for chronic lower back pain. The decision had an immediate impact on sales at surface stimulation companies like DJO, Dynatronix, and RS Medical.

Fortunately, some recent developments in the industry are serving to counteract this negative development. One such development is the advent of new modalities of surface stimulation, including surface VNS devices from Cerbomed and electroCore and surface trigeminal nerve stimulation systems from NeuroSigma. As we report on page 1 of this issue, the FDA recently approved a new surface stimulation device as preventative treatment for migraine headaches. And as we report on page 8, the NIH is funding research on transcranial DC stimulation as a potential therapy for stroke rehabilitation. Each of these new therapies lends credence to overall market for surface stimulation system.

But perhaps the most meaningful development in the surface stimulation industry has been a counterattack by DJO Global to demonstrate the economic viability of TENS for treatment of back pain. As we report on page 5 of this issue, DJO released a financial impact study that shows that CMS could save $417 million annually by supplying TENS in place of other treatments for low back pain. The study evaluated patients who were given TENS compared with a statistically matched group without TENS for 1-year prior to intervention and for 1-year of follow-up. Patients who were treated with TENS had significantly fewer hospital and clinic visits, used less diagnostic imaging, had fewer physical therapy visits, and required less back surgery than patients receiving other treatment modalities. Furthermore, TENS is non-invasive and non-narcotic, so it does not have the risks associated with other treatment approaches.

“Medicare still has to treat and pay for those suffering from chronic low back pain and may be overspending to achieve what is arguably poorer clinical outcomes that do not always relieve pain and discomfort, ”said Michael Minshall, senior director of health economics and reimbursement at DJO Global.

While manufacturers of implantable neurotech devices may not be too impressed with reports like this, there is common cause between surface and implanted stimulation vendors, a point Cyberonics has made by investing in Cerbomed. Indeed, vendors who offer both invasive and noninvasive therapies for a particular disorder may benefit from a more robust product line as well as a migratory path from one system to another.

James Cavuoto

Editor and Publisher

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