Spinal Modulation Axium™ Spinal Cord Stimulator System (SCS) Shows Promise in Managing Chronic Pain in Difficult Pain …

LAS VEGAS, Nev.--(BUSINESS WIRE)--

During the scientific sessions at the 16th Annual NANS Conference, Dr. Liong Liem, Anesthesiologist at Sint Antonius Ziekenhuis in the Netherlands and member of the Neuromodulation Appropriateness Consensus Committee (NACC), presented on the 12-month results of the first clinical trials to evaluate the safety and performance for CE-Mark approval of the Spinal Modulation Axium SCS System. Dr. Timothy Deer, Director of the Center for Pain Relief in Charleston, West Virginia and President-Elect for the International Neuromodulation Society (INS), discussed the potential of the dorsal root ganglion (DRG) as a neuromodulation target for treating difficult post surgical neuropathies, amputation pain, and complex regional pain syndrome (CRPS) based on international clinical trial experience.

In the United States alone, approximately 100 million people (30% of the population) suffer from pain and over 4 million of these people cope with chronic, neuropathic pain lasting longer than 6 months. Pain as a disease is crippling not only to patients but also society. Each year $635 billion are lost due to health care payments and lost wages (source: Neuroinsights, 2011, Frost and Sullivan).

Long-Term Results

In 2011, Dr. Liong Liem also presented on the initial results of the two prospective studies during the 15th Annual NANS Conference. This year he was awarded a podium presentation on the long-term results from these two international prospective studies. Thirty-two patients from four [pain] centers were enrolled in the study. The diagnoses included failed back surgery syndrome, CRPS, post-surgical neuropathic pain, and radicular pain. At 12 months, the average pain relief was 60% overall. Each patient was also evaluated by specific anatomical location. For those patients with foot pain, the pain relief in the foot at 12 months was 82%. For patients with leg pain, the anatomical specific pain relief at 12 months was 66%. All data indicated statistically significant improvements. In addition, secondary outcomes were also assessed including quality of life, functional ability, psychological disposition, and postural effects. All secondary outcomes also showed statistically significant improvements.

This is a therapy that shows great promise without the potential side effects of traditional SCS systems. Patients experience pain relief with minimal unwanted paresthesia and limited postural effects that is sustainable due to the lead stability (less than a 3% revision rate). It is a therapy that has changed my practice in Europe, said Dr. Liem during his presentation on his poster in the Sunday session. Managing pain from peripheral neuropathies resulting from procedures such as mesh hernia repair, is very difficult with current treatment modalities, including traditional Spinal Cord Stimulation.

Dr. Deer presented on three international posters that were on display at NANS, highlighting the international experiences in managing neuropathic groin pain, post-amputation pain and CRPS of the lower extremities.

Neuropathic Groin Pain

According to Liem, et al, neuropathic groin pain associated with hernia repair occurs in over 10% of patients after damage or entrapment of the ilioinguinal nerve from transection, inflammatory processes, excess fibrotic reaction, mesh encasement, or injury during open and laparoscopic repair. The results that were presented from retrospective data in Europe indicated an average visual analog score (VAS) reduction of 81% in 14 patients with an average follow-up of 14 weeks. Over 90% of the patients experienced a 50% reduction in pain.

Managing Post-Amputation Pain

See original here:
Spinal Modulation Axium™ Spinal Cord Stimulator System (SCS) Shows Promise in Managing Chronic Pain in Difficult Pain ...