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News

World's smallest rechargeable neurostimulator receives twin approvals

St Jude Medical : 14 April, 2008  (New Product)
St Jude Medical has received US Food and Drug Administration (FDA) and European CE Mark approvals for its Eon Mini, the world's smallest, longest-lasting rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.
Slightly larger than the circumference of a US silver dollar, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29g (approximately 1.0oz). The device’s 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.

'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, Pennsylvania, USA. '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.'

Even with its small size, the Eon Mini has the longest-lasting battery life of any rechargeable spinal cord stimulation (SCS) device in its class. The device is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the FDA. For patients this means 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.

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.

In addition, the Eon Mini device features the following:

- 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.

- Advanced programming capability that allows physicians to treat up to eight pain areas simultaneously to address complex pain patterns.

- A 16-contact header that is compatible with all St Jude Medical SCS leads, giving physicians more control in designing the system for optimal pain relief.

'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 optimising sustainable therapy.'

The Eon Mini design is based on the field-proven platform of the Eon neurostimulator and almost three years of performance data and improvements to the device. The device will be available in both the USA and Europe in the third quarter of 2008.

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.
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