St Jude Medical gains US and EU approval for mini 10-year rechargeable  neurostimulator

18 April 2008

St Jude Medical, Inc. (NYSE:STJ) has gained US FDA and European CE Mark approval for its Eon Mini rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.

The company says it is the world’s smallest, longest-lasting rechargeable neurostimulator. Slightly larger than the circumference of a US silver dollar, the Eon Mini is 10 mm thick, weighs 29 grams (approximately 1.0 oz) and has a battery life of 10 years between recharges.

Its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients. The device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings. The device’s battery longevity also may mean that patients require fewer battery replacement surgeries.

“Device size is an important consideration for many patients. The thin, small design should increase patient comfort, making it ideal for those whose body type requires a small device,” said Steven Rosen MD, of Fox Chase Pain Management Associates in Philadelphia, Pa. “Along with its dimensions, the device’s ability to provide high power output and long periods between recharges should make this an appealing option for many patients.”

The Eon Mini also allows patients the freedom to comfortably recharge the device’s battery while taking a walk, cooking a meal or shopping because the charging system is fully portable. Additionally, Eon Mini has the greatest recommended implant depth of any small rechargeable SCS device, so the device can be placed more discreetly, potentially making it less noticeable.

“The Eon Mini reflects our commitment to developing clinically relevant products to meet the needs of chronic pain patients,” said Chris Chavez, president of St. Jude Medical’s ANS Division. “Not only is Eon Mini the smallest, longest-lasting rechargeable neurostimulator available, it gives physicians and their patients more choices and more control in optimizing sustainable therapy.”

Neurostimulators like the Eon Mini and Eon are similar in function and appearance to cardiac pacemakers, delivering mild electrical pulses to the spinal cord, which interrupt or mask the pain signals’ transmission to the brain. More than 35,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.

Chronic pain is a serious public health issue that remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the US suffer from chronic pain. In Europe, the World Health Organization estimates that one in five people live with chronic pain of moderate severity.

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