FDAnews Device Daily Bulletin

ANS RECEIVES EU EC MARK CLEARANCE FOR EON

May 10, 2006
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Advanced Neuromodulation Systems (ANS), which designs implantable devices to manage chronic pain and other nervous system disorders, today announced it has received European EC Mark clearance for its Eon Rechargeable Neurostimulation System. ANS also announced the first European patient implant of the Eon System.

The CE Mark can only be placed on products that meet critical health and safety requirements of all EU directives.

The Eon Neurostimulation System helps patients manage chronic, intractable pain of the trunk and limbs by using low-intensity electrical impulses to selectively trigger nerve fibers along the spinal cord, the company said.

Featuring the highest-capacity rechargeable battery on the market, the Eon implantable pulse generator is designed to allow patients to go longer between battery replacement surgeries and allow clinicians more programming options to better manage the patient's pain, the company said.