Therapy Areas: Devices
Axonics's Sacral Neuromodulation system for the treatment of urinary and bowel dysfunction receives approval from Health Canada
7 November 2018 -

Axonics Modulation Technologies Inc (NASDAQ: AXNX), developer of the rechargeable Sacral Neuromodulation (r-SNM) system urinary and bowel dysfunction treatment, declared on Wednesday that it has received Health Canada approval (Homologation d'un instrument medical) to market its External Trial System, an additional element of the Axonics r-SNM system.

The company added that it had previously received Health Canada approval for its miniaturised rechargeable implantable neurostimulator, tined lead, patient and clinician programmers, charger and related accessories. The External Trial System is used to help identify responders to Sacral Neuromodulation therapy prior to a permanent implant. It is composed of a temporary, single-use disposable external stimulator that is connected to either a Tined Lead or a temporary Peripheral Nerve Evaluation (PNE) Lead, depending on the preferred trial method.

Currently, Axonics is conducting a 129-patient pivotal clinical study for urinary incontinence patients under a US FDA Investigational Device Exemption. The enrolment and implant phase was completed in late June 2018 and the company said it expects to file a pre-market approval (PMA) application for FDA approval in the US after the six-month post-implant endpoint has been reached.

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