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Fort Lauderdale

Holy Cross Hospital Exterior with Stained Glass Night Photo

Fort Lauderdale hospital is one of up to 25 centers in the nation to pioneer new treatment

FORT LAUDERDALE, Fla. – Holy Cross Hospital in Fort Lauderdale announced that it will participate in a U.S. pivotal clinical study aimed at establishing the safety and efficacy of the investigational Axium™ Neurostimulator System for patients with chronic lower limb pain. Among the first sites in the country to join the ACCURATE study, Holy Cross is one of up to 25 centers across the United States that will participate in the study. 

The Axium Neurostimulator System, developed by Spinal Modulation, Inc. of Menlo Park, is a small implanted device that delivers stimulation to a specific branch in the spinal cord called the dorsal root ganglion to interrupt pain signals before they travel to the brain. While this therapy is approved throughout Europe and Australia, the device is for investigational use only in the U.S.
Current treatments face challenges targeting chronic neuropathic pain in the feet, legs and groin. Utilizing the standard approach of spinal cord stimulation, the Axium system applies that therapy directly to the area that processes pain signals from the peripheral nerves. Recently published European data from a non-randomized study is encouraging and reports that 78 percent of participants experienced pain relief in the lower limbs.  

Every year, millions of Americans are affected by chronic neuropathic pain, impacting their ability to lead productive working, social and family lives. Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness, and few long-term treatment options exist.

Neuropathic pain is induced by an injury or disease of the nervous system such as Complex Regional Pain Syndrome. According to a study published in the British Journal of Anaesthesia, another common cause is chronic post-surgical pain, which affects up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations.

Common current treatment options for chronic neuropathic pain of the lower limbs include: physical therapy; prescribed medication such as antidepressants, anticonvulsants, and opioids; interventional procedures such as steroid injections or nerve blocks and neurostimulation techniques including spinal cord stimulation.

To qualify for the ACCURATE Study, participants must be between the ages of 22 and 75, have had chronic pain affecting lower limbs for at least 6 months and have not seen lasting success with other treatments or previously used spinal cord stimulation for chronic pain.

Individuals interested in additional information on the ACCURATE Study are encouraged to visit www.ACCURATEStudy.com, or call 1-888-978-8397.

About Holy Cross Hospital

A member of CHE Trinity Health, Holy Cross Hospital in Fort Lauderdale, Fla. is a full-service, non-profit Catholic hospital, sponsored by the Sisters of Mercy. Since opening its doors in 1955, the 559-bed hospital has offered progressive services and programs to meet the evolving healthcare needs of Broward County. Today, Holy Cross has more than 600 physicians on staff representing more than 40 specialties and more than 3,000 employees. To learn more about Holy, visit holy-cross.com, “like” Holy Cross Hospital, Fort Lauderdale on Facebook, or follow @holycrossfl on Twitter.

About Axium™ Neurostimulator System
The Axium Neurostimulator System is the only form of spinal cord stimulation (SCS) that targets a specific branch of the spinal cord 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. It is limited to investigational use in the United States.
About the ACCURATE Study

The ACCURATE Study is a prospective, randomized, multi-center, controlled study to evaluate the safety and efficacy of Spinal Modulation’s Axium Neurostimulator System for the treatment of chronic pain affecting the lower limbs. Key ACCURATE study qualifications include the following: 1) age 22 to 75 years; 2) chronic pain affecting lower limbs for at least 6 months; 3) has not had lasting success with other treatments; and 4) has not previously used spinal cord stimulation for chronic pain. To learn more about the ACCURATE Study, visit www.ACCURATEstudy.com or call 1-888-978-8397.

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 (or just use DRG, you have discussed it above). Spinal Modulation is a global medical device company based in Menlo Park, Calif, 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, ePlanet Ventures, Raffles Venture Partners, The Angels Forum and The Halo Fund.