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International Research on the Dorsal Root Ganglion (DRG) Presented at the 18th Annual North American Neuromodulation Society (NANS) Congress Shows Promise for the DRG as a Target for Neuromodulation

2014年12月16日 AM02:18
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LAS VEGAS

At the 18th annual North American Neuromodulation Society (NANS) congress, researchers presented 20 international, peer-reviewed scientific abstracts from Australia and Europe highlighting clinical results of the Axium™ Neurostimulator System for the treatment of chronic, intractable pain.

Chronic post-surgical pain

Two single center, retrospective reviews from Australia and an international retrospective case review demonstrated improvement in pain scores and reduced disability in patients suffering from chronic post-surgical pain. Highlights include:

  • (Verrills P., Mitchell B., Vivian D. et al.) A long-term single-center study of 29 patients implanted with the Axium Neurostimulator System reported 66% pain reduction at 12 months. The Oswestry Disability Index (ODI)—a measure of disability for low back pain—decreased from 43.7 at baseline to 25.6 at 12 months, a 41% improvement.
  • (Espinet A.) A single-center review of 16 patients with chronic post-surgical pain affecting different anatomies (abdomen, knee, upper leg, etc.) presented 77.2% pain relief at 6 months.
  • (Verrills P., Espinet A., Mitchell B. et al.) A multi-center review of 13 patients with intractable knee pain after surgery reported average pain relief of 71.2% (mean follow-up of 6 months).

Upper Limb Neuropathy

Prospective data pooled from four European studies (Huygen FJPM., Baranidharan G., Simpson K. et al.) reported pain relief and improved quality of life for 16 patients with upper limb neuropathies including CRPS, post-amputation pain, peripheral nerve injury, and post-surgical radicular pain. Highlights include:

  • Pain Relief: Median VAS at baseline and 6 months were 82 and 30, respectively, a 52.7% improvement.
  • Quality of Life: Mean EQ-5D Index scores showed improvement in quality of life, increasing from 0.252 at baseline to 0.757 at 6 months.
  • Subjects did not experience changes in paresthesia with body position changes. Paresthesia is a tingling sensation associated with spinal cord stimulation that replaces the pain sensation.

Visceral Pain

A retrospective observational study (Baranidharan G. and Das S.) presented early positive outcomes for 9 patients treated for abdominal visceral pain. Highlights include:

  • Pain Relief: Average VAS reduction of 34.4 mm (mean follow up of 9.7 months).
  • Quality of Life
    • Mean EQ-5D index score improved from 0.004 to 0.569 after treatment.
    • The EQ-5D health status improved from 36.6 to 67.7.
    • The most noticeable changes in EQ-5D profiles were in pain and depression/anxiety levels.
    • Average reduction in opioid usage at last follow-up was 147.7 mg or 62.1%. Three out of the seven patients that were on morphine pre-treatment completely stopped their intake.

“The data shows that this targeted form of spinal cord stimulation may be a promising treatment option for multiple chronic pain conditions that can be hard to treat with conventional spinal cord stimulation,” said Bruce Mitchell, MD of Metro Pain Group in Australia, and one of the researchers at NANS. “In particular for post–surgical chronic pain, which represents a large patient population group that is otherwise underserved, the technique shows great promise.”

All research topics highlighted above are from use of the Axium Neurostimulator System in Europe and Australia. In the United States, the Axium Neurostimulator System is restricted to IDE investigational use.

About Chronic Pain

Chronic neuropathic pain is a condition that affects millions of Americans annually, impacting their ability to lead productive working, social and family lives. Neuropathic pain is induced by an injury or disease of the nervous system. The most common location for neuropathic pain is the lower limbs; including areas such as the legs, feet, and groin area. Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness.

About the Axium® Neurostimulator System

The Axium Neurostimulator System is a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain. The Axium Neurostimulator System has CE Mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain.

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, Belgium, and Australia. The company is funded by St. Jude Medical, Johnson and Johnson Development Corporation, Medtronic, Kleiner Perkins Caufield and Byers, De Novo Ventures, MedVenture Associates, DFJ InCube Ventures, DFJ ePlanet Ventures, Raffles Venture Partners, The Angels Forum and The Halo Fund. In June 2014, St. Jude Medical signed an equity investment and option to purchase Spinal Modulation. The agreement provides St. Jude Medical immediate international distribution rights for the Axium Neurostimulator System and a longer term exclusive option to acquire the company following the achievement of certain milestones.

CAUTION: The Axium Neurostimulator System is an investigational device and is limited by United States law to investigational use.

SPINAL MODULATION, the circle symbol and AXIUM are registered and unregistered trademarks of Spinal Modulation, Inc. and its related companies.

©2014 Spinal Modulation, Inc. All rights reserved.

CONTACT

Spinal Modulation
Claudia Holy, +44 7795 607106
Info@spinalmodulation.com

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