FDA approves Vertis' system for treatment of lower back pain

מתוך medicontext.co.il
By Ori Twersky

WASHINGTON (Reuters Health) – Medical device maker Vertis Neuroscience Inc. said on Wednesday that it received clearance from the US Food and Drug Administration (FDA) to market a percutaneous neuromodulation therapy (PNT) for the treatment of lower back pain.

The Seattle, Washington-based concern said that the therapy would be marketed under the name Vertis PNT and would be launched immediately.

PNT is the application of electrical therapy to treat diseases and disorders affecting the central nervous system (CNS).

The privately held concern said that the FDA approval was based on clinical studies, demonstrating that PNT could provide substantial pain relief to a wide range of people with lower back pain. The Vertis PNT delivers electrical stimulation directly to the deep tissues to modulate the nerve pathways that can affect pain, the company explained.

The company estimated that about 30 to 40 million Americans who currently suffer from lower back pain could benefit from the electrical therapy. It said that the annual direct and indirect cost of treating lower back pain alone presently totals about $100 billion a year in the US, when accounting for treatments ranging from aspirin to surgery.

"The Vertis PNT System offers physicians a minimally invasive and cost-effective treatment approach that will serve as a valuable alternative, or adjunct, to current low back pain treatments," said Vertis CEO Dr. Alan J. Levy in a statement.

"The use of a low-risk option early in the process may reduce the number of patients who progress to the chronic stage, where pain can become intractable and lead to long-term disability," added Dr. Richard Seroussi, the company's medical director.

The Vertis PNT system is the first such system to be approved in the US, according to Vertis Co-founder John Harris. "We are not aware of anyone else that has even applied for approval of a PNT system," he told Reuters Health.

Harris added that the price tag for physicians will be around $5,000 for the control unit and $80 per patient kit. As a result, he said that the treatment cost per patient is expected to range from $200 to $300.

Harris also noted that the unique aspect to this treatment is that delivers the electrical shock below the skin, making electrical therapy a realistic option for a greater number of patients.

He noted that the company is planning to test the system for upper back pain.

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