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Rechargeable neurostimulator receives FDA and CE Mark approvals of extended 10-year battery life claim

St Jude Medical : 14 February, 2008  (New Product)
St Jude Medical has received US Food and Drug Administration (FDA) and European CE Mark approvals of a 10-year battery longevity claim for the Eon neurostimulator, a rechargeable device used to treat chronic pain.
With neurostimulation therapy, devices with rechargeable batteries have quickly become the standard. At high stimulation parameters, a 10-year-old Eon device will maintain at least 24 hours of continuous therapy between recharges. For patients, this means the Eon device can provide sustainable therapy and maintain a reasonable recharge interval for 10 years, potentially resulting in fewer battery replacement surgeries.

Rechargeable neurostimulators are designed with a battery reserve to protect the device from damage should a patient discontinue therapy. The Eon neurostimulator's battery reserve allows the device to be safely recharged for up to 18 months after stimulation has been discontinued.

'We continually strive to develop best-in-class products that enhance patients' quality of life,' said Chris Chavez, president of St Jude Medical's ANS Division. 'The addition of battery life-extending technology, which enables the 10-year battery capability, is a prime example of our commitment to making a good product even better.'

Introduced in March 2005, the Eon neurostimulator was upgraded in September 2006 with NeuroDynamix technology, a proprietary microchip and enhanced software design, which contribute to the increased battery efficiency. The claim was granted after St Jude Medical monitored the device's performance since the initial product introduction in 2005.

Neurostimulators like the Eon system are designed to provide spinal cord stimulation (SCS) therapy to treat complex neuropathic pain of the trunk and limbs or pain from failed back surgeries. Similar in function and appearance to cardiac pacemakers, these devices deliver mild electrical pulses to the spinal cord, interrupting or masking 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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