Image credit: Affluent Medical
Walking down MD&M Minneapolis’ aisles, I saw an implantable device that I hadn’t seen before. It is an artificial mechanical sphincter being developed by Affluent Medical based in Aix-en-Provence, France. The device is aimed at treating stress urinary incontinence, which is a disabling condition that results in uncontrolled urinary leakage during effort such as coughing or sport.
Image Credit: Axonix
Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.
The jury ruled unanimously for Axonics, on claims related to three separate patents. One relates to transcutaneous recharging, and the other two two to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.
The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.
First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering
In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.
Image Credit: Axonix
In January of this year Boston Scientific announced it had entered into a definitive agreement to acquire Axonics a publicly-traded developer of devices to treat urinary and bowel dysfunction. The purchase price was set at $3.7B. However, the proposed deal is facing scrutiny by the FTC, most probably because the companies are dominant providers of some treatments for incontinence.
The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation (SNM) therapy. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.
Image Credit: UroMems
UroMems was founded in 2011 in Grenoble, France. They are developing the UroActive™ implantable device to treat Stress Urinary Incontinence (SUI), or involuntary urinary leakage, which affects an estimated 40 million Americans and 90 million Europeans, and occurs when the pressure in the bladder exceeds that of the sphincter around the urethra.
The “MyoElectroMechanical System (MEMS)” is placed around the urethral duct and is designed to be automatically controlled based on the patient’s activity, without the need for manual adjustments.
According to UroMems, “The expected benefit of the UroActive™ device is twofold. First, the urethral pressure can be increased when the patient is engaged in a physically demanding activity, which is expected to improve continence during activity. Second, when the patient’s activities do not require increased pressure, the compression on the urethral tissue can be released, therefore potentially reducing erosion or other tissue damage.”
The first human implant of the device was performed in November of 2022, and a 6 male subject feasibility study reached its six-month endpoint last December. The Company announced today that its first female patient had reached the six-month endpoint.
Image Credit: Axonix
Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Axonics, a company that develops implantable sacral neuromodulation devices to treat urinary and bowel dysfunction. According to the announcement, the purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion.
Image Credit: Zamora et al https://doi.org/10.1101/2020.09.10.292284
Amber Therapeutics has acquired fellow U.K.-based Bioinduction, a for its Picostim DyNeuMo platform. The implantable device was originally designed as a deep-brain stimulation device for the treatment of Parkinson’s disease. However, Amber intends to utilize it first as a pudendal nerve stimulator for treating mixed urinary incontinence, where patients experience symptoms of both stress and urge incontinence.
The device is currently being trialed in Belgium as part of a 15 female subject pilot study to evaluate its safety and efficacy.
Image Credit: Valencia Technologies
On March 1, 2022 FDA approved Valencia Technologies’ eCoin Peripheral Neurostimulator System to stimulate the tibial nerve to treat Urge Urinary Incontinence. The eCoin system delivers electrical pulses to the tibial nerve in 30-minute sessions based on a fixed schedule. A healthcare provider can adjust the level of stimulation based on each patient’s sensitivity and needs, using the remote control.
Image Credit: Bluewind Medical
On August 17, 2023, the FDA authorized marketing for BlueWind Medical’s Revi System, a Tibial Neuromodulation System intended for use in the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. The device consists of an active implantable wireless neurostimulation component intended to be placed in the vicinity of the tibial neurovascular bundle for peripheral nerve stimulation. Since the implant has no battery, the wearable unit transmits energy via magnetic coupling to the implant, which consequently generates electrical pulses stimulating the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord, relieving symptoms of urinary incontinence alone or in combination with urinary urgency.
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: Neuspera Medical
Neuspera Medical is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that they closed a $65M series C equity financing round to fund their trial on the use of their device in patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder. The Series C round was co-led by Vertex Ventures HC and Treo Ventures.
Neuspera’s website: http://neuspera.com
Image Credit: Neuspera Medical
Neuspera is a startup company located in San Jose, CA. They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.
According to Neuspera, their “Mid-Field Powering” technology uses evanescent and propagating electromagnetic waves to power implanted medical devices to beyond 10cm of depth. Their technology is claimed to use the body as a natural waveguide to focus power ensuring energy is delivered to where it is needed.
In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE. Neuspera now announced that it had performed the first human implants as part of their SANS-UUI two-stage seamless pivotal clinical trial to support FDA approval for patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder.
Neuspera’s website: http://neuspera.com
Image Credit: Neuspera Medical
Image Credit: Bioness
Bioness announced that its StimRouter received the CE-Mark to Treat Fecal Incontinence.
Unlike most externally-powered neurostimulators, the StimRouter is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead. Continue reading
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.