Smallest Neurostimulator Device Approved
St. Jude Medical, Incorporated received FDA clearance for the Eon Mini. This device is currently the smallest neurostimulator device available on the market. It is indicated to treat patients with chronic pain after failed back surgery or in the limbs or trunk. St. Jude Medical issued a press release describing marketing approval of the device.
The Eon Mini is small, just larger than the circumference of a U.S. silver dollar. The device is about 10mm thin and weighs in at 1.0 ounce. The device is the longest-lasting rechargeable neurostimulator on the market; the FDA approval for the battery is ten years.
The Eon Mini includes constant current circuitry, this automatically adjusts its power output across time to deliver therapy at a constant rate. An advanced programming feature supports treatment of complex pain patterns; clinicians can treat up to eight distinct pain areas at the same time. As well, the device header includes 16-contacts and is compatible with all the SCS leads currently available from St. Jude’s.
The ten year battery longevity provides long-term device sustainability. It is expected to maintain a reasonable recharge interval over a ten year period, even at high settings. Longer battery life may minimize the number of surgeries required to replace batteries.
This small size allows for placement using a smaller incision. These features provide clinicians with a broader array of options with respect to determining the ideal location for implantation. An additional benefit of the smaller profile is that implantation is more comfortable for patients and the site is less visible.
April 15, 2008 Related topics: Product Approval & Certification, Psychiatry & Neurology