Advanced Neuromodulation Systems (ANS), the neuromodulation business of St. Jude Medical, Inc, today announced Australian Therapeutic Goods Administration (TGA) regulatory approval for its Eon Rechargeable Neurostimulation System. In Australia, the Eon system is fully reimbursable via the private health system.
Patients at the Pain Management Research Institute, Royal North Shore Hospital in Sydney, were among the first to receive the Eon system. Pain Medicine Specialist Professor Michael Cousins, M.D., who performed one of the first surgeries, said, "Eon was easy to implant and the patients continue to gain substantial pain relief. With its rechargeable battery, Eon is a good option for patients who require high-power stimulation settings and need to use the system for a large percentage of the day."
Eon delivers spinal cord stimulation (SCS) therapy to treat chronic, intractable pain of the trunk and limbs, including pain associated with failed back surgery syndrome. Similar to a cardiac pacemaker, this "pacemaker for pain" uses mild electrical pulses from leads selectively placed near the spinal cord to interrupt pain signals to the brain.
Eon contains the highest-capacity rechargeable battery available, which is designed to last a minimum of seven years at high-power settings. This allows patients to go longer between battery replacement surgeries. The rechargeable technology is easy for patients to understand and use – they simply recharge the device periodically, similar to recharging a mobile phone. Eon can power up to 16 independent electrodes, which allows clinicians more programming options to better manage the patient's pain.
"Approval of the Eon system provides physicians in Australia with a new tool to combat chronic pain," said Chris Chavez, president of ANS. "The full power of the Eon system is realized when coupled with advanced clinician programming features of Rapid Programmer 3.0, such as Dynamic MultiStim and Active Balancing. Eon and this programming platform work together as an integrated system to provide clinicians greater speed, precision and effectiveness in addressing complex pain."
Chronic pain is a largely under-treated and misunderstood disease that affects millions of people worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that "One in five people suffers from moderate to severe chronic pain, and one in three is unable or less able to maintain an independent lifestyle due to pain." Spinal cord stimulators like Eon often allow patients to greatly reduce their need for potent and potentially addictive pain medication.
Eon was approved by the U.S. Food and Drug Administration in 2005. Approximately 25,000 patients in more than 25 countries around the world use ANS neurostimulation devices to manage chronic pain.