www.fdanews.com/articles/187529-axonics-implantable-neurostimulator-receives-ce-mark
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Axonics’ Implantable Neurostimulator Receives CE Mark
July 9, 2018
Axonics was granted a CE Mark for its sacral neuromodulation external trial system, used in treating patients with urinary and bowel dysfunction.
The external trial system consists of a temporary, single-use stimulator that is connected to either a tined lead or peripheral nerve stimulator lead, depending on the trial method.
The trial system is an extension of the Axionics sacral neuromodulation system and is used to help identify patients responsive to sacral neuromodulation therapy before a permanent implant is installed.