Axonics is the latest company to get a US neurostimulator approval

Snippets

Yesterday's green light for Axonics Modulation Technologies’ implanted sacral neuromodulator, r-SNM, for faecal incontinence is just the start for the product – the group expects a further US approval for urinary incontinence by the end of the year. The device stimulates the sacral nerves in the pelvic area, and is intended for patients who have failed on, or are unsuitable candidates for, drug therapy or other treatments. The device’s USP is that it can be recharged through the skin, which Axonics believes will allow it to carve out a niche from Medtronic. Medtronic’s Interstim devices, the first of which was approved in the US in 1997, is the main sacral nerve stimulator on the US market but cannot be recharged; when it runs out of juice it must be surgically removed and replaced. Axonics must make the most of this advantage: Medtronic plans to launch a rechargeable version of Interstim II in 2020. Neuromodulation devices continue to be approved or cleared by the FDA for a wide range of indications – the last two years have seen approvals for opioid withdrawal, heart failure and even cancer.

Selected US neurostimulator approvals of the last two years
Device Company Type of stimulator Indication Date
r-SNM Axonics Modulation Technologies  Sacral nerve stimulator Faecal incontinence Sep 9, 2019
Barostim Neo  CVRx Carotid sinus nerve stimulator Heart failure Aug 16, 2019
IB-stim Innovative Health Solutions Non-implanted neurostimulator Pain associated with IBS Jun 7, 2019
NovoTTF-100L Novocure Low electric field tumour treatment Cancer May 23, 2019
Nerivio Migra Theranica Non-implanted neurostimulator Migraine May 20, 2019
Monarch Neurosigma Non-implanted neurostimulator ADHD Apr 19, 2019
Brainsway Brainsway Non-implanted neurostimulator OCD Aug 17, 2018
Cala One Cala Health Non-implanted neurostimulator Upper limb tremor Apr 26, 2018
TNM Scion Neurostim Non-implanted neurostimulator Headache Mar 26, 2018
Vercise Boston Scientific Deep brain stimulator Parkinson’s symptoms Dec 8, 2017
NSS-2 Innovative Health Solutions Non-implanted neurostimulator Opioid withdrawal Nov 15, 2017
Source: EvaluateMedTech, company communications.

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