FDAnews Device Daily Bulletin

U.S., Europe Approve New Claim for Neurostimulator

Feb. 15, 2008

St. Jude Medical has received FDA and European CE Marking approvals of a 10-year battery longevity claim for its Eon neurostimulator, a rechargeable device for chronic pain.

The company received the clearance after monitoring the device’s performance since its 2005 introduction.

Rechargeable neurostimulators are designed with a battery reserve to protect the device should a patient discontinue therapy. The reserve allows the device to be safely recharged for up to 18 months after therapy has been discontinued, according to St. Jude.