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Spinal Modulation System Receives CE Mark for the Management of Chronic Intractable Pain

Fri, 12/09/2011 - 5:45am

LAS VEGAS--(BUSINESS WIRE)--Spinal Modulation, a privately held global medical device company, announced today that the Spinal Modulation Neurostimulator System has received the CE Mark for the management of chronic intractable pain. The Spinal Modulation System utilizes low-level electrical signals to modulate neural structures of primary sensory neurons located within the dorsal root ganglion (DRG). These cell bodies have been implicated in the development and maintenance of chronic pain conditions.

Dr. Liong Liem and Dr. Paul Verrills will present the initial results of the worlds first multicenter prospective clinical trial to assess the management of chronic pain through stimulation of the DRG on December 11, 2011 in Las Vegas during the Annual NANS Conference.

"The Spinal Modulation system has provided substantial benefit to a number of my patients with chronic intractable pain that have not had adequate pain relief with other Spinal Cord Stimulation (SCS) systems. For example, patients with chronic intractable pain in the lower extremities are typically very difficult to treat with existing SCS systems. With the Spinal Modulation System, I have seen very encouraging results in patients with this type of pain condition," said Dr. Liong Liem, Director of the Pain Management Practice at Sint Antonius Hospital in The Netherlands and one of two presenters at NANS.

Neurostimulation therapy is a proven method of managing chronic pain. It uses an implantable medical device to deliver mild electrical pulses to neural tissue to mask or interrupt pain signals as they travel to the brain. With dorsal column spinal cord stimulation, small wires are placed along the midline of the epidural space. With the Spinal Modulation therapy, physicians place a specialized neuromodulation system in the epidural space to target the DRG, which allows the signals to be masked or interrupted even before they enter the spinal cord.

"Spinal Modulation has taken a deliberate and scientific approach to developing this therapy. My practice has partnered with Spinal Modulation to help demonstrate the clinical utility of neuromodulation of the DRG in patients with chronic, intractable pain. I am very enthusiastic that they have developed practical and clinically useful tools for long-term stimulation of the DRG and I look forward to its commercial availability in my practice in Australia," said Dr. Marc Russo, Director of the Hunter Pain Clinic in Newcastle, Australia.

The company has begun international commercialization and plans to continue clinical research in order to advance DRG stimulation and provide pain relief for more patients.

About Spinal Modulation

Spinal Modulation is dedicated to improving the lives of patients with chronic pain by providing the next generation of neuromodulation systems through stimulation of the dorsal root ganglion. Spinal Modulation is a global medical device company based in Menlo Park, CA. The company is funded by Johnson and Johnson Development Corporation, Medtronic, Kleiner Perkins Caufield and Byers, De Novo Ventures, MedVenture Associates, and DFJ_InCube Ventures. For more information, please visit www.spinalmodulation.com or contact Spinal Modulation at info@spinalmodulation.com.

Caution - The Spinal Modulation Neurostimulator System is not approved for use or sale in the United States.

Posted by Sean Fenske, Editor-in-Chief, MDT

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