Image Credit: Axonix
On March 7, 2022 Axonix announced that it had received FDA Approval for its 10cc F15 Recharge-Free Sacral Neuromodulation System for the treatment of bladder and bowel dysfunction. The device features 15+ years of functional life at typical stimulation parameters and 20+ years at lower energy settings.
Image Credit: Medtronic
Medtronic announced that it received approval from the U.S. Food and Drug Administration (FDA) for its InterStim X™ sacral neuromodulation system for the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.
According to the announcement, the InterStim X device features a proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years.
Image Credit: Medtronic
Medtronic announced today that it had submitted its new InterStim™ Micro neurostimulator and matching InterStim™ SureScan™ MRI leads for PMA approval by FDA.
According to the press release:
“InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval.”
It’s not common for companies to announce their submissions – usually one waits for approval – but this may be Medtronic’s way of signaling the market that it’s not far behind Axonics, which received FDA approval for a similar device last month.
Image Credit: Axonics
Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.
The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.
The r-SNM device won CE Mark approval in June 2016. Axonics announced today that it had received FDA approval for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term.
Image Credit: Axonics
Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.
The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.
The r-SNM device won CE Mark approval in June 2016, and is currently pursuing FDA approval using its “literature-based PMA submission”. This type of submission relies on supporting literature that is “sufficient, detailed, objective, and directly applicable to the subject device.” Axonics is quoting the Medtronic InterStim II device, which is the only U.S.-approved sacral neurostimulator. Axonics also provided to FDA one-year post-market data from its 51-patient European Relax-OAB study.
In February 2019 Axonics announced that its IDE pivotal clinical study demonstrated that patients implanted with the r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, met all secondary endpoints, and no serious device-related adverse events were reported.
Axonics had an Initial Public Offering in November 2018 which yielded $138M.
Axonics website: http://www.axonicsmodulation.com/
Image Credit: Axonics