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

Category Archives: Therapies

AIMDs classified according to general type of therapy

CorTec’s Closed-Loop Brain Interchange system receives IDE approval for use in rehabilitation from stroke

Posted on by Posted in Brain Stimulation, CorTec, Stroke
CorTec Closed-Loop Brain Interchange implant system

Image Credit: CorTec

CorTec is a neurostimulation company based in Freiburg, Germany developing the closed-loop “Brain Interchange Implant System.”  This is an implantable device is capable of recording and stimulating on 32 channels under the wireless control of an External Unit which also powers the device.  Application Software on a computer connected to the External Unit manages the telemetry and analyzes signals acquired by the implant.  The computing unit then uses parameters provided by the application software to generate stimuli in the brain and nerves.

CorTec announced  that the US FDA approved and IDE application by the University of Washington School of Medicine to use the Brain Interchange Implant System as a novel stroke rehabilitation treatment using cortical stimulation to enhance plasticity within the brain. Continue reading→

Senseonics receives FDA iCGM Designation for Eversense® CGM System

Posted on by Posted in Diabetes, Glucose Monitoring, Senseonics, Sensors
Eversense® Implantable Continuous Glucose Monitoring System

From: Lorenz, Carrie & Sandoval, Wendolyn & Mortellaro, Mark. (2018). Interference Assessment of Various Endogenous and Exogenous Substances on the Performance of the Eversense Long-Term Implantable Continuous Glucose Monitoring System. Diabetes Technology & Therapeutics. 20. 10.1089/dia.2018.0028.

Senseonics in Germantown, MD announced that its Eversense® Implantable Continuous Glucose Monitoring System has received the iCGM designation by the FDA.  iCGM status indicates that Senseonics’ Eversense iCGM product can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.

According to the announcement:

“As the first fully implantable device in the category, Eversense has been authorized to be marketed as an iCGM through the FDA’s De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.

…  The companies plan to advance partnership discussions with various pump manufacturers, with plans to offer people who choose to integrate their diabetes devices a new interoperable CGM option that is exceptionally well suited for AID systems. This is because Eversense addresses common limitations of AID systems outlined in the 2022 Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.”

The Eversense subcutaneously implantable glucose sensor has been validated for up to 180-day implant periods.  Unlike other  CGM systems that use
electrochemical- and enzymatic- (i.e., glucose oxidase and glucose dehydrogenase) based methods to measure glucose concentrations, the Eversense CGM sensor uses an abiotic (non–enzyme based), fluorescent glucose-indicating polymer to measure glucose.

FDA Approves Medtronic’s Inceptiv™ Closed-Loop SCS

Posted on by Posted in Medtronic, Pain, Spinal Cord Stimulation
Medtronic Inceptiv SCS

Image Credit: Medtronic

Medtronic announced that it received FDA’s approval for its Inceptiv™ closed-loop spinal cord stimulation system for the treatment of chronic pain.

According to the press release:

“Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device’s stimulation output, resulting in a suboptimal therapy experience.

By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician’s prescribed stimulation that is tailored to a patient’s needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body’s response to stimulation 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.”

History: The Pacesetter Rechargeable Human Tissue Stimulator

Posted on by Posted in Alfred E. Mann, Dr. Robert Fischell, Epilepsy, Museum, Neural Stimulation, Pacesetter, Pain, Wireless Power Transmission
Pacesetter Human Tissue Stimulator

Pacesetter Human Tissue Stimulator (HTS) (c) David Prutchi, Ph.D., 2024

I recently acquired this device on eBay® (from a very kind seller, I may add).  Although labeled as a “Rechargeable Pacemaker,” and looks just like the one at the Udvar-Hazy about which I had posted a few years ago, it is in fact a neurostimulator.

The Human Tissue Stimulator or “HTS” was developed subsequently to the rechargeable pacemaker, prompted by the clinical need for a rechargeable implantable neurostimulator.

Continue reading→

Teliatry’s ReStore Stimulator

Posted on by Posted in Neural Stimulation, PNS, PTSD, Spinal Cord Injury (SCI), Teliatry, Texas Biomedical Device Center, Vagus Nerve Stimulation
Teliatry's ReStore neurostimulator

Image Credit: Teliatry

Teliatry is a company based in Richardson, TX that is developing the ReStore batteryless, wireless neurostimulator.  The glass-encased stimulator was developed in collaboration with the Texas Biomedical Device Center (TXBDC) at The University of Texas at Dallas.

A first device using this stimulator is a Vagus Nerve Stimulator with integrated platinum electrodes, for which TXBDC has received FDA approval for pilot studies in the treatment of PTSD  and to enhance recovery following a spinal cord injury.  Teliatry expects their platform to be also usable for superficial (< 4cm deep) nerve stimulation delivering up to 5mA pulses, as well as a neuromodulation R&D platform suitable for studies involving small animals.

Synergia Medical’s NAO·VNS™ Optoelectronic Neurostimulator

Posted on by Posted in Biophan, Epilepsy, MRI-safe, Photovoltaic, Synergia Medical, Vagus Nerve Stimulation
Synergia NAO.VNS optoelectronic stimulator for epilepsy

Image Credit: Synergia Medical

Synergia Medical is a Belgian company founded in 2014 developing a neurostimulation system that powers the stimulation electrodes by photovoltaic conversion of light pulses produced by a generator connected via optical fiber.

The concept is to reduce major metallic components such that the device can be operated while the patient undergoes a functional MRI (fMRI), and hence, according to Synergia, allow the device’s performance to be assessed and optimized at the time of implant. Continue reading→

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.

Continue reading→

FTC scrutinizing Boston Scientific’s $3.7B bid to acquire Axonix

Posted on by Posted in AIMD Business, Axonics, Boston Scientific, Incontinence, Sacral Root Stimulation
Axonix rechargeable stimulator

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.

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

Flowonix Medical, NJ’s implantable infusion pump company

Posted on by Posted in Drug Delivery, Epilepsy, Flowonix, Pain, Spasticity
Flowonix Prometra implantable drug pump

Image Credit: Flowonix Medical

Yesterday I was chatting with a friend regarding the medical device industry in NJ, and realized that I never posted a blog on Flowonix based in Mount Olive, NJ.

Flowonix was founded in 2005 (then called Medasys).  It received approval to conduct its first clinical trial in 2007 on the Prometra programmable implantable pump. The company received approval by the FDA to market the Prometra in 2012 to deliver Infumorph.

Continue reading→

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.

Continue reading→

Presidio Medical’s Ultra-Low Frequency (ULF) SCS for Pain

Posted on by Posted in Nerve Blocking, Pain, Presidio Medical, Spinal Cord Stimulation
Presidio Medical ULF

Image Credit: Presidio Medical

Presidio Medical is a San Francisco-based private company founded in 2017 to develop neuromodulation devices based on the delivery of ultra-low frequency (ULF) signals.

The idea is to use very low frequency biphasic currents to achieve the same type of blocking effect that DC Direct current has on the propagation of nerve action potentials, but without damaging tissues.

A paper published in Science in 2021 on Presidio-sponsored studies conducted with ULF signals showed that a ULF waveforms produced a rapidly-developing and completely reversible conduction block in animal models.  The same paper reported on a 2-week human trial that tested the analgesic effects of epidural ULF currents in 20 subjects with chronic leg and back pain. Pain ratings improved by 90% after 2 weeks and returned to 72% one week after lead explant.

In June 2023, Presidio announced that it had received $72 million Series C funding round led by Deerfield Management, existing investors Invus Opportunities and Action Potential Venture Capital, and joined by ShangBay Capital.  Presidio is using these funds to expand their team, scale manufacturing, and conduct long-term, pivotal clinical studies of the ULF™ SCS system.

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→

Former Stimwave CEO Found Guilty of Selling Non-Functional Neurostimulators

Posted on by Posted in AIMD Business, Curonix, News, Pain, PNS, Spinal Cord Stimulation, Stimwave Technologies
Stimwave injectable neurostimulator system

Image Credit: Stimwave Technologies

Stimwave Technologies was founded by Laura Tyler Perryman in 2010 to develop wireless injectable neurostimulation devices.

The Freedom® stimulator is composed of a stimulating electrode array and a receiver element  containing a dipole antenna and stimulation circuitry configured to receive energy from an externally-placed antenna through radiative coupling.

Stimwave receiver

From: Vannemreddy, Prasad & Perryman, Laura & Janaswamy, Jyotsna & Slavin, Konstantin. (2019). Minimally Invasive Wireless Spinal Cord Stimulation: A Novel Approach for Refractory Angina in Women. Indian Journal of Cardiovascular Disease in Women WINCARS. 04. 10.1055/s-0039-3402829.

Great idea!

However, Stimwave’s problems started soon after the introduction of the StimQ peripheral nerve stimulation device.  The issue was that physicians were having trouble implanting the “pink stylet” receiver component in certain patients because it was too long. This is when Laura Tyler Perryman ordered the creation of a “white  stylet” “receiver” that could be cut to length by the physicians.  The issue however was that the component was made of all plastic, with no circuitry inside, and misrepresented it to doctors as an alternative to the receiver component.

According to the U.S. Attorney prosecuting the case, Perryman directed Stimwave employees to vouch for the efficacy of the white stylet as a receiver and oversaw training for doctors suggesting the component was functional.  Insurance companies, including Medicare, were charged $16,000 to $18,000 between 2017 through 2020 for the non-functional “receiver.”

After the fraud was exposed, Laura Tyler Perryman resigned as Stimwave’s CEO in November 2019.   She was arrested  in March 2023.   In December, the U.S. Securities and Exchange Commission charged Perryman with defrauding investors out of about $41 million.  This week (March 6, 2024), a jury unanimously found Perryman guilty of committing healthcare fraud and conspiracy to commit healthcare fraud and wire fraud.  The count of healthcare fraud carries a maximum penalty of 10 years, and the count of conspiracy to commit healthcare and wire fraud carries a maximum sentence of 20 years in prison.

In July 2020 Stimwave recalled the device and in June 2022 filed for
Chapter 11 bankruptcy protection, sold most of its assets, and ceased its operations.  In November 2022, Curonix of Pompano Beach, Florida completed the purchase of  Stimwave Technologies’ assets and liabilities.