A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Muscular Stimulation

AIMDs for muscular stimulation

What happened to the BION®?

Posted on by Posted in Advanced Bionics, Alfred E. Mann, Axonics, Bluewind Medical, Boston Scientific, Electrode Materials, General Stim, Incontinence, Muscular Stimulation, Nalu, Neural Stimulation, Neuspera, Paralysis, University of Southern California, Valencia Technologies
RF-powered Bion stimulator

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.

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eAxon injectable neurostimulator being developed at Pompeu Fabra University

Posted on by Posted in Muscular Stimulation, Neural Stimulation, Pompeu Fabra University
eAxon

Image Credit: Pompeu Fabra University

Prof. Antony Ivorra’s Biomedical Electronics Research Group at Pompeu Fabra University in Barcelona is developing an injectable neurostimulator that they call the eAxon Electronic Axon.

The thread-like IPG is externally powered using high-frequency, volume-conduction currents delivered transcutaneously by an wearable transmitter through electrically-conductive fabric in contact with the skin.  The same currents enable bi-directional communication between the external transmitter and the implant, enabling not only stimulation of deep-seated nerves and muscles, but also sensing, and hence opening the possibility of closed-loop control.

The IPGs contain a microcontroller-based circuit, so multiple IPGs can be implanted and controlled by a single transmitter.  Furthermore, unlike inductively-powered devices, the tansmitter does not need to be precisely positioned over the implant locations.

Details about the system are presented in detail through a series of videos in the main eAxon page. Click on the image below for a high-resolution pdf copy of the eAxon flyer: eAxon Flyer:

 

eAxon Flyer jpg image

Image Credit: eAxon

Super Vision’s i-NYS implantable device for the treatment of congenital nystagmus

Posted on by Posted in Nystagmus, Rectus Muscle Stimulation, Super Vision
Super Vision i-NYS implantable device for the treatment of Congenital Nystagmus

Image Credit: Super Vision

Super Vision was founded in Beijing in 2018 by professors from the Peking University and Beijing University of Technology.  It developed the i-NYS implantable stimulation device for the treatment of congenital nystagmus – a condition where the eyes move rapidly and uncontrollably.

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China’s Evolving Domestic AIMD Industry

Posted on by Posted in Aerospace Taixin Technology, AIMD Business, Bradycardia, Brain Stimulation, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, CH Biomedical (Tongxin Medical Equipment), Circulatory Support, Cochlear Stimulation, Core Medical Technology, CoreRhythm, General Stim, Genlight, Hearing Impairment, Heart Failure (CHF), Leadinno Medical Valley, Lepu Medical, Lifetech Scientific, Microport, Nerve Blocking, Nurotron, Nystagmus, Pain, Parkinson's Disease, PINS Medical, PNS, Qinming Medical, Rectus Muscle Stimulation, Rishena Medical, Rocor Medical Technology, Sacral Root Stimulation, Sceneray, Seeneuro, Singular Medical, Sneuro, Spinal Cord Stimulation, Super Vision, Tachycardia, Vagus Nerve Stimulation, Yongrenxin

AIMDs made in China www.implantable-device.com

The 2015 “Made in China 2025” and subsequent domestic development initiatives have significantly benefited Chinese medical device manufacturers.  The 2015 plan  prioritized the expansion of high-tech device production with the goal of supplying 70% of China’s device market by 2025.   More recently, in 2021, the Chinese government issued the 14th  five-year plan (2021–25) that aims at making at least six Chinese companies reach the top 50 revenue-making medical device companies globally.

I was recently chatting with Victor Pikov at the First AIMD Workshop, and he mentioned that in the last couple of years the number of Chinese AIMD manufacturers have grown from 5 to over 10.  I was really surprised about the progress that China has made in the AIMD field, so this blog expands on the list of Chinese AIMD companies that Victor compiled and kindly shared with me. Continue reading→

FDA Approves Mainstay Medical’s ReActiv8 Neurostimulator

Posted on by Posted in Mainstay Medical, Muscular Stimulation, Pain

Image Credit: Mainstay Medical

Dublin, Ireland-headquartered Mainstay Medical announced that FDA has approved its ReActiv8 neurostimulator is intended to treat chronic low back pain caused by arthrogenic muscle inhibition.  This is a neuroprotective condition in which the brain reflexively attempts to limit motor stimulation and movement in muscles surrounding a joint in response to damage or injury to the joint. In patients with this type of back pain, an initial injury triggers this reflexive inhibition, and the brain tries to limit painful movement by altering nerve transmissions to the deep stabilizing muscles of the spine, causing a loss of motor control, an unstable spine, and greater susceptibility to reinjury.

According to Mainstay, arthrogenic muscle inhibition causes the vicious cycle of recurring pain, instability, and reinjury commonly seen in patients with chronic nonspecific low back pain.  The ReActiv8 System attempts to interrupt this cycle by using neurostimulation to reactivate the motor control system driving the deep stabilizing muscles of the spine.  Stimulation is delivered via two leads which are placed bilaterally near the medial branch of the dorsal ramus nerve at the L3 vertebra.  An external wireless activator is used to start and stop stimulation sessions typically for 30 minutes twice a day.

According to the announcement:

“The FDA approval grants Mainstay the right to market ReActiv8 in the United States as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.”

Mainstay’s Medical ReActiv8® for Lumbar Spine Muscle Stimulator for Chronic Low Back Pain

Posted on by Posted in Muscular Stimulation, Pain

Image Credit: Mainstay Medical

Mainstay is a European medical device company headquartered in Dublin, Ireland. Mainstay has developed the ReActiv8® implantable neurostimulator intended for helping people with disabling Chronic Low Back Pain.

The ReActiv8® implantable neurostimulator is designed to electrically stimulate nerves to key stabilizing muscles of the lumbar spine thereby activating these muscles. The concept is that restoration of muscle activation is an important step in the treatment of chronic low back pain.

The ReActiv8® includes two leads which are placed bilaterally near the medial branch of the dorsal ramus nerve at the L3 vertebra, and are connected to the IPG. CE approval for the device was granted in May of 2016.

According to Mainstay, the therapy is similar to exercise programs used to restore muscle control in that ReActiv8 sessions are delivered twice a day for about 30 minutes under the patient’s via a handheld wireless remote control.

Mainstay expects that over time, the stimulated activation will help the patient’s brain and body learn how to better control the muscles in between sessions, and thus recover from chronic low back pain.

Mainstay’s Medical website: http://www.mainstay-medical.com

Cleveland FES Center’s Networked Neural Prosthesis

Posted on by Posted in Brain-Computer Interface, Cleveland FES Center, Muscular Stimulation, Paralysis, Spinal Cord Injury (SCI)

Cleveland FES - Networked Neural Prosthesis (NNP) system, www.implantable-device.com, David Prutchi, Ph.D.

The Cleveland FES Center was established in 1991 as a consortium between the Cleveland VA Medical Center (CVAMC), the private educational institution of Case Western Reserve University (CWRU), and the public hospital system of MetroHealth Medical Center (MHMC).

As part of this consortium, Dr. Hunter Peckham – biomedical engineering professor at Case Western Reserve University – and his group have developed the Networked Neuroprosthetic System (NNPS), which is based on a network of small implanted modules they call “neuroprosthetic building blocks”.  These modules are distributed throughout the body, and each is dedicated to a specific function.  Modules are linked to a centralized power source via a network cable through which they also communicate with each other.

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Mainstay Medical’s Reactiv8 to Treat LBP Caused by Arthrogenic Muscle Inhibition

Posted on by Posted in Mainstay Medical, Muscular Stimulation, Pain, Spinal Cord Stimulation

logo_mainstay1[1]

Mainstay Medical was founded in 2008 by entrepreneur Dr. Danny Sachs. The company’s ReActiv8 neurostimulator is intended to treat chronic low back pain caused by arthrogenic muscle inhibition.  This is a neuroprotective condition in which the brain reflexively attempts to limit motor stimulation and movement in muscles surrounding a joint in response to damage or injury to the joint. In patients with this type of back pain, an initial injury triggers this reflexive inhibition, and the brain tries to limit painful movement by altering nerve transmissions to the deep stabilizing muscles of the spine, causing a loss of motor control, an unstable spine, and greater susceptibility to reinjury.

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NDI Medical’s Miniature MicroPulse Neurostimulator

Posted on by Posted in Incontinence, Medtronic, Muscular Stimulation, NDI Medical, Pain, Paralysis, Spinal Cord Stimulation, SPR Therapeutics, Wireless Power Transmission
NDI Medical MicroPulse rechargeable neurostimulator
Image Credit: SPR Therapeutics

NDI Medical was founded in 2002 by Geoffrey B. Thrope to develop and commercialize neurodevice products.  NDI Medical developed the MicroPulse neurostimulator, a thumb-sized, rechargeable pulse generator, that has been used for the treatment of incontinence and pain, as well as an implantable device for the restoration of function of paralyzed limbs.

According to a 2006 news release by the electronics assembly manufacturer for the MicroPulse:

“Using minimally-invasive surgery, the Micropulse is implanted into a patient, usually in the lower abdomen or buttock, where the device is most comfortable and least visible. After implantation, a clinician uses a wireless programmer to set the Micropulse’s stimulus parameter and timing patterns. The programmer, as well as the patient’s controller for the device, has a range of about three feet.

To recharge the device’s lithium-ion battery, the patient applies a recharging patch for several hours to the vicinity of the implant. The battery needs recharging from once a month to every few weeks.” Continue reading→

Victhom Human Bionics’ Neurostep Implantable Closed-Loop Stimulator for Foot Drop

Posted on by Posted in Foot Drop, Muscular Stimulation, Victhom Human Bionics
Neurostep stimulator for drop-foot
Image Credit: Victhom Human Bionics

Victhom Human Bionics was founded in 2002 in Saint-Augustin-de-Desmaures, Canada. The company’s Neurobionix business unit develops its implantable closed-loop system devices.

The Neurostep® is a neurostimulator designed to be implanted into the patient’s leg. Electrodes are attached to the peripheral nerves responsible for sensing and stimulating the muscles that lift the foot during normal walking. In operation, the device senses key physical events and stimulates the muscles of the ankle flexing the foot upward in patients suffering from foot drop.

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BioControl’s MiniatURO Muscle Stimulator to Alleviate Incontinence (1999-2006)

Posted on by Posted in BioControl, Incontinence, Muscular Stimulation, Yossi Gross (Rainbow Medical)

BioControl's MiniatURO implantable muscle stimulator for the treatment of incontinenceBioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel.  BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis.  In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynaecology and other pelvic health applications.

The BioControl MiniatURO was an implantable muscle and nerve stimulator designed for subcutaneous implantation on an outpatient basis. Its purpose was to alleviate some types of urinary incontinence.

For patients suffering from stress incontinence, whenever the device detected an increase in abdominal pressure through its pressure-sensing catheter, it applied mild electrical pulses to the pelvic floor muscles. The intention was to activate the muscles and prevent inadvertent urine loss. In the urge incontinence mode of operation, the unit applied mild electrical pulses to the pelvic diaphragm nerve, using the sphincter detrusor muscle reflex to inhibit bladder contractions. For those with both types of incontinence, the two modes of operation were combined.  In operation, the unit was intended to mimic natural physiology, activating the muscle upon demand, and strengthening the pelvic floor muscle. Continue reading→

BioControl’s CardioFit System for the Treatment of Heart Failure via Vagus Nerve Stimulation

Posted on by Posted in BioControl, CerebralRx, Heart Failure (CHF), Hypertension, Muscular Stimulation, Vagus Nerve Stimulation, Yossi Gross (Rainbow Medical)
Biocontrol's Cardiofit Vagus Nerve Stimulator for Heart Failure Treatment

BioControl Medical, Ltd. was founded in 1999 by Yossi Gross, and is based in Yehud, Israel.  BioControl’s first devices were developed to treat incontinence due to overactive bladder, stress, and interstitial cystitis.  In 2006 American Medical Sytems acquired an exclusive license for the use of the technology in urology, gynecology and other pelvic health applications. Continue reading→