St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of the Eon Mini™ spinal cord stimulation (SCS) system. The world's smallest, longest-lasting rechargeable neurostimulator, the Eon Mini device is the first rechargeable spinal cord stimulator to be approved for use in Japan. Spinal cord stimulators manage chronic pain of the trunk or limbs and pain from failed back surgery by delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.
“Neurostimulation offers chronic pain patients a therapy that can deliver sustainable relief”
Slightly larger than the typical man's watch, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approximately 1 oz). Additionally, the device has the greatest recommended implant depth of any rechargeable SCS device. The thin profile and greater implant depth potentially makes the neurostimulator less noticeable and more comfortable for patients. Its small size also allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location.
"Neurostimulation offers chronic pain patients a therapy that can deliver sustainable relief," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "The Japanese approval of the Eon Mini neurostimulator represents an important step toward broadening the availability of this therapy."
Even with its small size, the Eon Mini neurostimulator has the longest-lasting battery life of any rechargeable spinal cord stimulation device currently on the market. It is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval. This means the device should provide sustainable therapy and maintain a reasonable recharge interval for at least 10 years of use at high settings. The device's battery longevity also may mean that patients require fewer battery replacement surgeries.
In addition, the Eon Mini device features the following:
- Advanced programming capability that allows physicians to manage up to eight pain areas simultaneously to address complex pain patterns.
- A 16-contact header that is compatible with all St. Jude Medical neurostimulation leads, giving physicians more control in designing the system for optimal pain relief.
- Enhanced microchip and software (NeuroDynamix™) technology that continuously selects the most efficient power management mode, preserving the battery's capacity to deliver therapy.
- Constant current circuitry that automatically adjusts power output to deliver consistent therapy over time.
- Fully portable charging system that allows patients the freedom to comfortably recharge the battery while taking a walk, cooking a meal or shopping.
"With the Eon Mini neurostimulator we are now able to offer physicians a best-in-class product to help them meet the needs of patients who require a smaller, long-lasting rechargeable system in order to manage their chronic pain," said William Phillips, president of St. Jude Medical Japan. "The launch of the Eon Mini spinal cord system -- the first rechargeable technology in Japan -- is an excellent addition to our growing portfolio of neurostimulation products available from St. Jude Medical Japan."
Chronic pain is a largely under-treated and misunderstood condition that affects millions of patients worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain.
Three decades of leading edge neurostimulation technology
More than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation therapy at www.PowerOverYourPain.com or www.sjm.co.jp/general/nerve/index.html.
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