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

Sat, 12/08/2012 - 8:00pm
The Associated Press

LAS VEGAS, Nev.--(BUSINESS WIRE)--Dec 8, 2012--During the scientific sessions at the 16 th 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 15 th 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 International data presented in a poster by Dr. Katja Bürger, anesthesiologist at the Rijnland Hospital in Leiderdorp, The Netherlands, suggested that another type of post-surgical pain might be managed with the Spinal Modulation therapy. Data suggests that 41% - 85% of patients have pain associated with the stump or phantom limbs. A retrospective case series from Europe was presented highlighting 3 patients treated with the Spinal Modulation Axium SCS System. The average pain relief was >50% pain relief. The poster described a case study of an amputee who was injured during a missile attack in Afghanistan. This particular patient has now been living with the Spinal Modulation Axium SCS System for 5 months and carries on a normal life The system is able to steer the stimulation into the phantom foot in order to relieve the pain. This was consistent across the cohort of patients.

Treating CRPS of the Lower Extremities International data was also presented for patients with complex regional pain syndrome. CRPS is a condition that can be characterized as pain and dysfunction of the sympathetic nervous system in one region of the body, usually an extremity. Treatment modalities include pharmacological, non-pharmacological, and surgical interventions. Dr. Jean-Pierre Van Buyten, Chairman of the Pain Center at AZ Nikolaas clinic in Belgium, presented on his initial international experience from seven patients during the Friday plenary session. "In my experience, a significant problem in treating CRPS with traditional SCS has been therapy coverage of the foot. Traditional SCS can provide broad coverage of the legs, but to reach the deep dorsal column fibers associated with the foot requires high stimulation parameters that leads to broad and uncomfortable stimulation. A new solution is the dorsal root ganglion. My CRPS patients treated with SCS of the DRG have shown reduction in pain and swelling, specific pain coverage without extraneous stimulation, and increases in quality of life," said Dr. Van Buyten during his lecture on Friday in the NANS scientific session. The average overall pain relief in the foot was recorded as 82.9% in these 7 patients.

Caution: The Axium™Spinal Cord Stimulator System is currently an investigational device in the United States and is not approved for use in the United States.

Spinal Modulation will be initiating its pivotal IDE clinical trial early in 2013 in the United States.

Spinal Cord Stimulation therapy is indicated in Europe for 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™ SCS system, a specialized system is placed in epidural space near the DRG, allowing pain signals to be modulated.

The Axium SCS System has both CE Mark and TGA approval in Australia and the therapy is helping patients at centers around the world. Spinal Modulation was founded in 2006 based on spinal cord stimulation targeting the dorsal root ganglion and has treated over 150 patients worldwide. Spinal Modulation is an established medical device manufacturer based in Menlo Park, CA and with operations in Diegem, Belgium. The company is funded by Johnson and Johnson Development Corporation, Medtronic, Kleiner Perkins, De Novo Ventures, Medventures, and InCube Ventures. For more information, please visit www.spinalmodulation.com or contact Spinal Modulation at info@spinalmodulation.com.

CONTACT: Spinal Modulation Dan Brounstein, +1 650-703-8436 (Mobile) Vice President, Market Development Area Director Benelux/Nordics Dan@spinalmodulation.com KEYWORD: UNITED STATES EUROPE NORTH AMERICA NETHERLANDS CALIFORNIA NEVADA INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CLINICAL TRIALS MEDICAL DEVICES SOURCE: Spinal Modulation Copyright Business Wire 2012 PUB: 12/08/2012 08:00 PM/DISC: 12/08/2012 08:00 PM http://www.businesswire.com/news/home/20121208005036/

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