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

Category Archives: Neural Stimulation

AIMDs for the stimulation of the nervous system

ShiraTronics raises $66M for pivotal trial treating migraine

Posted on by Posted in Cluster Headaches, Migraine, Occipital Nerve Stimulation, ShiraTronics

 

ShiraTronics Implantable device for the treatment of migraine

Image Credit: ShiraTronics

Broolin Park (MN)-based ShiraTronics  developed a system that is intended to provide electrical stimulation to nerves associated with migraine pain. The therapy includes a temporary Trial System and a permanent Implant System. The Trial System components include percutaneous leads temporarily placed in the supraorbital and occipital regions. The Implant System components include rechargeable IPGs with integrated leads. The IPGs are implanted in subcutaneous pockets posteriorly on the head with leads tunneled to the supraorbital and occipital regions. Both systems are controlled by a programmer with a therapy application.

This summer ShiraTronics presented 12-week results on 10 patients enrolled its pilot clinical trial in Australia of its implantable system intended for the prophylactic treatment of refractory chronic migraine.

ShiraTronics announced yesterday the closing of a $66 million Series B financing.  According to the press release:

“This latest round of funding will support ShiraTronics’ recently launched U.S. Food and Drug Administration (FDA)-approved pivotal trial, the RELIEV-CM2 Clinical Study, a multi-center, blinded, randomized, sham-controlled clinical trial. The trial is designed to evaluate the safety and effectiveness of the company’s Migraine Therapy System in patients who have failed current medical therapies and have treatment-resistant chronic migraine. The financing also will support the company as it seeks premarket approval from the FDA and fund the initial commercial launch of its innovative therapy for chronic migraine patients.”

Axonics Prevails in Patent Infringement Lawsuit with Medtronic

Posted on by Posted in AIMD Business, Axonics, Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation, Wireless Power Transmission
Axonix rechargeable stimulator

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.

 

Comphya’s CaverSTIM System to treat Erectile Disfunction

Posted on by Posted in Cavernous Nerve Stimulation, Cirtec, Comphya, Erectile Disorder
CaverSTIM IPG for ED by Comphya

Image Credit: Comphya

Comphya is a company based in Lausanne, Switzerland developing a system for the treatment of erectile disorder due to spinal cord injury or prostatectomy.

The CaverSTIM System is based on the Algovita Platform which was acquired by Cirtec when Nuvectra declared bankruptcy.

The IPG provides self-controlled stimulation (via a wireless remote control) to the cavernous nerve to restore natural erectile function. According to Comphya, their innovation has a key element which can overcome a major barrier for the therapy, the complex anatomy of the neural path for erection, and it can guarantee the identification of the site for stimulation within the pelvic cavity.   Comphya has tested this in an acute clinical trial (J Sex Med. 2018 Nov;15(11):1558-1569).

Their first implant took place in August 2023 at the Royal Melbourne Hospital.  In October of 2023, the device was first implanted in a spinal cord injury patient at Hospital Mario Covas in Brazil. More recently, in August 2024 Comphya announced that it had received approval from the Brazilian National Research Ethics Committees (CEP and CONEP) and the federal regulatory authority ANVISA to initiate a pilot clinical trial in patients undergoing prostatectomy.

CaverSTIM system by Comphya

Image Credit: Comphya

Neuralink receives FDA’s Breakthrough Device designation for its Blindsight Device

Posted on by Posted in Blindness, Brain Stimulation, Neuralink
Neuralink implant

Image credit: Neuralink

Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA.  According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”

Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.

Update on Device Based Therapies in Heart Failure published by HFSA

Posted on by Posted in Abbott, Baroreceptor Stimulation, Berlin Heals, Biotronik, Boston Scientific, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, Cardioversion/Defibrillation, Circulatory Support, CVRx, Edwards, Endotronix, Heart Failure (CHF), Impulse Dynamics, Medtronic, Microcurrent, Respicardia, Ventricular Assist Device, Viscardia
From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

The Heart Failure Society of America (HFSA) published today a new Scientific Statement titled “Update on Device Based Therapies in Heart Failure.”  The statement was published online in the Journal of Cardiac Failure (JCF).

This statement discusses how novel device-based therapies, including CCM, BAT, and remote monitoring may bridge current gaps in HF treatment and outcomes.  The statement also proposes a clinical pathway to implement FDA approved device-based therapies that align with current HF management workflow.

 

 

Abbott starts clinical trial of DBS to treat depression

Posted on by Posted in Abbott, Brain Stimulation, Depression
Abbott St Jude Medical Infinity DBS IPG

Image Credit: Abbott

Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder.  Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.

Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.

Continue reading→

FDA recalls 32 Inspire model 3028 IPGs

Posted on by Posted in Inspire Medical, Neural Stimulation, Obstructive Sleep Apnea, Sleep Apnea

Image Credit: Inspire Medical

FDA has recalled 32 Inspire IV model 3028 IPGs due to a manufacturing defect which can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the neurostimulator IPG and restore therapy for obstructive sleep apnea.

According to the recall announcement:

“The use of affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in – loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.

There have been no reported injuries. There have been no reports of death.”

Picostim DBS device implanted in child with Lennox-Gastaut syndrome

Posted on by Posted in Amber Therapeutics, Bioinduction, Brain Stimulation, Epilepsy, Lennox-Gastaut syndrome
Picostim DyNeuMo

Image Credit: Zamora et al https://doi.org/10.1101/2020.09.10.292284

UK news outlets reported that a Picostim deep-breain stimulator made by UK company Bioinduction (which was recently acquired by Amber Therapeutics) was recently implanted in a boy with Lennox-Gastaut syndrome, which is a  a severe,  treatment-resistant form of epilepsy that he developed at the age of three.

The implant was performed at the UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital under the “CADET” project (Children’s Adaptive Deep brain stimulation for Epilepsy Trial).  According to the project’s website, the Picostim system is especially suitable for DBS therapy in this application:

  1. “The advanced capabilities of Picostim DyNeuMo-1 allow for personalised and adaptive stimulation regimes according to seizure patterns and circadian (wake/sleep) rhythms at an individual patient level, which are key components of LGS symptoms. These capabilities are here proposed to maximize the potential of DBS to limit seizure spread, and reduce seizure frequency and severity.

  2. These capabilities are made possible by the ability to non-invasively and repeatedly recharge the device. Patients or parents are able to use a handheld or headset-mounted charger that safely recharges the battery through the skin.

  3. The device allows for the recording of electrical activity in the implanted brain, potentially allowing stimulation parameters that are tailored to LGS and to the individual child.

  4. Lastly, the whole device is mounted to the skull, removing the need for (painful) tunneling of extension leads to a battery implanted in the chest wall and potentially reducing the risk of infection.”

The CADET pilot (Children’s adaptive deep brain stimulation for epilepsy trial) will now recruit three additional patients with Lennox-Gastaut syndrome, with a view to 22 patients being recruited to take part in a full trial.

 

 

CADET Project is using a cranially-mountedPicostim DBS device

Image Credit: CADET Project, UCL Great Ormond Street Institute of Child Health

 

Science acquires assets and clinical studies from Pixium Vision SA

Posted on by Posted in Blindness, Optogenetics, Pixium Vision, Retinal Stimulation, Science

Pixium Vision’s Prima System. Image Credit: Images by Pixium Vision

Science – the company recently started by Neuralink’s co-founder Max Hodak announced that it is acquiring Pixium Vision‘s assets.

Pixium Vision’s Prima system to treat vision loss is implanted in 47 subjects across Europe and the United States.  However, it ran out of cash, and was in danger of abandoning the study.  Science’s acquisition of Pixium’s technology includes the three ongoing clinical trials in late-stage macular degeneration.

Science Eye

Image Credit: Composite of images by Science

On its side, Science is developing the “Science Eye,” which is a combination device comprising Optogenetic gene therapy and an implantable, high-resolution display.  The first part of the procedure consists of a protein nanoparticle used to deliver a gene to some of the retinal ganglion cells, making them light-sensitive at a specific wavelength.  Then, a very small, flexible, high-resolution display film is implanted over the retina to allow fine control of the newly light-sensitive ganglion cells.

In the announcement, Max Hodak stated about the acquisition of Pixium’s competing technology:

“What does this mean for our optogenetic gene therapy and the Science Eye? It’s too early to know which approach, electrical or optogenetic, will work best in the retina long term as these technologies mature. But whichever is used 20 years from now, there is a huge amount of good all of these early devices can do today. They represent very different approaches that make different tradeoffs and at least initially will probably target different patient subpopulations. We would love to be able to offer a range of products to match each individual patient’s needs with the best of what’s available over time.”

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→

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→