Bioness’ Chronic Pain Nerve Stimulator Gets FDA Nod

Valencia, Calif., devicemaker Bioness received 510(k) clearance from the FDA for its Stimrouter, an implantable neuromodulation device designed to treat chronic, intractable pain.

The minimally invasive, easy-to-use Stimrouter is indicated specifically for pain that emanates from the peripheral nerves, and offers a cost-effective alternative to pain medications, complex surgeries and other pain-management treatments, the company said.

About 50 million people in the U.S. suffer from chronic pain, at an annual cost to the U.S. healthcare system of $150 billion, according to the company. As such, there is a demonstrable need for affordable pain management options, Bioness said.

The device builds on the company’s other neuromodulation systems and allows it to expand into the pain management market, said President and CEO Todd Cushman. — Kellen Owings