
Axonics is the latest company to get a US neurostimulator approval
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 | ||||
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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. |