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.