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

Category Archives: Vagus Nerve Stimulation

Active implantable medical devices for vagus nerve stimulation

SetPoint Medical raises $140M to support commercialization of its rheumatoid arthritis therapy

Posted on by Posted in Rheumathoid Arthritis, SetPoint Medical, Vagus Nerve Stimulation

Image Credit: SetPoint Medical

On July 31, 2025, SetPoint Medical received FDA approval for its neuroimmune modulation device for the treatment of adults living with moderate-to-severe rheumatoid arthritis (RA) who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

FDA’s approval was based on the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System’s safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.  The study met its primary efficacy endpoint of ACR20 at three months, with improvements observed in ACR response rates and disease activity metrics through 12 months of follow-up. 75% of patients in the study were free of biologic or targeted synthetic DMARDs at 12 months.

This week SetPoint announced that it raised $140M in private financing.  According to the press release, proceeds of the financing will support commercialization of the SetPoint System, as well as advancement of the company’s pipeline in other autoimmune conditions.

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→

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→

Presenting Keynote “AIMD-based Therapies of Heart Failure” at LASCAS 2024

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, Circulatory Support, David Prutchi's Portfolio, Heart Failure (CHF), Hypertension, My Portfolio, Vagus Nerve Stimulation

LASCAS Keynote

I’ll be presenting the keynote “AIMD-based Therapies of Heart Failure” at the First Workshop on Active Implantable Medical Devices dedicated to understanding the trends and challenges in bioelectronic medicine.

For the complete announcement of the workshop with some great talks by Rikky Muller (UC Berkeley), Pedro Arzuaga (Impulse Dynamics), Marcelo Barú (Biotronik), Federico De Mula (Integer), and Victor Pikov (Medipace) click here:  AIMD Workshop LASCAS 2024 Program.

 

Merck and Spain’s INBRAIN Neuroelectronics to Collaborate in Development of Graphene-Based Vagus Nerve Stimulators

Posted on by Posted in INBRAIN, Inflammation, Merck, Rheumathoid Arthritis, Vagus Nerve Stimulation

INBRAIN Neuroelectronics S.L. was funded in Barcelona, Spain in 2019 as a spin-off from Graphene Flagship partners, the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and ICREA. Its subsidiary INNERVIA Bioelectronics is working towards the development and commercialization of graphene-based systems to modulate vagus nerve signals.

INBRAIN announced that it will be collaborating with Merck to co-develop the next generation of graphene bioelectronic vagus nerve therapies targeting severe chronic diseases in Merck’s therapeutic areas.

INBRAIN’s website is at:  www.inbrain-neuroelectronics.com

 

Livanova and Verily Start Depression Sub-Substudy Using Symmetry VNS IPG and Verily’s Health-Tracking Devices

Posted on by Posted in Depression, LivaNova, Vagus Nerve Stimulation

Image Credit: LivaNova

LivaNova and Verily announced that they have enrolled their first patient in a study to evaluate treatment effectiveness for patients living with depression.  From the press release:

“The first patient has been enrolled in their collaborative UNCOVER study or “The RECOVER Sub-Study, Which Leverages Quantitative and Credible Research Tools from Verily, Will Provide Assessment Measures for Depressive Episodes.”

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The UNCOVER sub-study deploys technology-enabled research tools from Verily to evaluate the real-world effectiveness of VNS Therapy as an adjunctive treatment for difficult-to-treat depression (DTD).

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Participants in the UNCOVER sub-study will use two Verily-developed digital tools – a wearable, multi-sensor device (Verily Study Watch) along with an Android smartphone application (Verily Mood App). The Verily tools measure passive and active data, such as the participant’s pulse rate, activity levels and sleep quality. The Mood App also allows participants to record voice diaries to more accurately assess depressive episodes and their effect on daily living.

…

Quantitative data obtained from these Verily tools will supplement the clinical outcomes collected in the RECOVER study, providing clinicians a more comprehensive view of whether each patient’s depression is improving, staying the same, or worsening.”

Setpoint Medical Receives FDA IDE Approval to Implant its “Microregulator” for Treating Rheumatoid Arthritis

Posted on by Posted in Rheumathoid Arthritis, SetPoint Medical, Vagus Nerve Stimulation

Image Credit: SetPoint Medical

SetPoint Medical is a company based in Valencia, California developing an implantable-device-based therapy for chronic autoimmune diseases.  It announced in May that it has received FDA IDE approval to study its device in patients with rheumatoid arthritis (RA).

The multicenter, double-blind, randomized, sham controlled pivotal trial will enroll up to 250 patients at 40 sites across the U.S. The trial will evaluate the safety and effectiveness of the SetPoint “microregulator” in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).

The Continuing CMS Coverage Saga of Cyberonics/LivaNova’s Vagus Nerve Stimulation for Treatment-Resistant Depression

Posted on by Posted in Cyberonics, Depression, LivaNova, Vagus Nerve Stimulation

LivaNova SenTiva VNS
Image Credit: LivaNova

Back in July, 2005, the FDA approved Cyberonics (now LivaNova) VNS implant for patients with chronic or recurrent depression, either unipolar or bipolar, with a history of failure of the depression to respond to at least four antidepressant interventions.

However, the U.S. Centers for Medicare & Medicaid Services (CMS) declined covering VNS for serious depression. CMS concluded back in 2007 that VNS’ effectiveness was not compelling enough to expand coverage, leaving drug-resistant epilepsy as its only covered indication.

Ten years later LivaNova presented data from a five-year study of VNS for treating TRD which showed that patients with chronic moderate to severe TRD experienced anti-depressant effects at a significant rate when treated with the therapy.

In response, last month (February 2019) CMS said:

“Based on the evidence, we believe that VNS for TRD seems promising but not convincing.” “To ensure benefits to Medicare beneficiaries we are proposing to cover VNS for the treatment of TRD when offered in double-blind, randomized, placebo-controlled studies.”

Continue reading→

MicroTransponder’s VNS Vivistim™ System Intended for the Treatment of Stroke

Posted on by Posted in Micro Transponder, Stroke, Tinnitus, Vagus Nerve Stimulation

Image credit: MicroTransponder

Back in 2013 I reported about MicroTransponder’s Serenity System™, which pairs Vagus Nerve Stimulation (VNS) with listening to tones. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation from the implantable vagus-nerve stimulator. UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”

More recently, MicroTransponder developed the Vivistim™ system intended for the treatment of stroke.   The implant is based on the idea that synchronizing vagus nerve stimulation with movement increases neural plasticity in the brain, resulting in enhanced recovery.

In May 2017 MicroTransponder presented results from its Vivistim™ Stroke Rehabilitation trial. The objective of this multicenter, double-blind, randomized, active-controlled trial was to improve upper limb mobility in stroke survivors suffering chronic disability. The data showed 75% of patients had a clinically meaningful response on the Fugl-Meyer Upper Extremity Scale (FMUE) at the end of a six weeks of physical therapy compared to 33% for the control group. 90 days after the six weeks of physical therapy ended 88% of VNS patients had responded compared to 33% in the control arm. And during the long-term portion of the study average FMUE scores continued to increase, with the 6 month and 9 month data showing further gains. All responders indicated they believed their overall health had improved and were satisfied with the therapy.

At the same time, MicroTransponder announced that it had received IDE approval from the FDA to run a 120-patient pivotal trial on the Vivistim™ system.

MicroTransponders website: http://www.microtransponder.com

Operation of Vivistim System
Image credit: MicroTransponder

EnteroMedics Reports Maestro Obesity Study Showing 25% Reduction in Excess Weight

Posted on by Posted in EnteroMedics, Obesity, Vagus Nerve Stimulation

EnteroMedics Maestro Obesity IPG David Prutchi PhD

EnteroMedics reported new clinical trial data for its Maestro system, which is designed to treat obesity through vagus nerve stimulation. The company said that its Maestro RC system lost 25% of their excess weight, or 10% of their total body weight, after 18 months. Patients who received a sham implant lost 12% of excess weight, or 4% of their total weight. The company is running a five-year study of the system.  The system is approved in Europe and Australia, but not the U.S.

 

 

Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Posted on by Posted in Cerbomed, Cyberonics, Depression, Epilepsy, Inflammation, Pain, Vagus Nerve Stimulation

Cerbomed tVNS non invasive vagus nerve stimulator

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems.

Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making it an attractive therapy option when compared to implantable vagus nerve stimulators.

The NEMOS tVNS system consists of a handheld stimulator and a dedicated ear electrode, which patients wear like an earphone.  According to Cerbomed, intensity, pulse duration and frequency of the t-VNS stimulation have been optimized to induce signals in thick-myelinated Aβ fibres of the ABVN. Like those of the cervical branch of the vagus nerve, these project directly to the nucleus of the solitary tract (NTS) in the brainstem.

In 2010 Cerbomed received the CE mark for its NEMOS® transcutaneous Vagus Nerve Stimulator for the treatment of epilepsy and depression. In 2012, the indication was expanded to include the treatment of pain.

In September 2012, Cerbomed entered into a strategic partnership with Cyberonics, Inc., the global market leader in vagus nerve stimulation.  Cyberonics made an initial investment of €2 million to fund Cerbomed’s epilepsy clinical trial in Germany, with further investments of up to €5.5 million, subject to the achievement of certain clinical milestones. Cyberonics is a minority shareholder with certain rights, including representation on Cerbomed’s advisory board and an exclusive option for worldwide sales and distribution of NEMOS.

 

European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Posted on by Posted in BioControl, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, CVRx, Heart Failure (CHF), Impulse Dynamics, Spinal Cord Stimulation, Vagus Nerve Stimulation

Implantable devices for the treatment of heart failure, David Prutchi, PhD

 

A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.

The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.

The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).

Continue reading→

MicroTransponder Raises Funds for Clinical Trials of Serenity VNS IPG for Treating Tinnitus

Posted on by Posted in Micro Transponder, Tinnitus, Vagus Nerve Stimulation

MicroTransponder Serenity IPG for treatment of Tinnitus David Prutchi PhD www.implantable-device.com

MicroTransponder, Inc. of Dallas, TX has raised $3.4 million to carry out clinical trials of its Vivistim System to help restore functionality in the upper limbs of stroke patients, and its Serenity System designed to “rewire” the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S.

According to the company’s website, the Serenity System™ pairs Vagus Nerve Stimulation (VNS) with listening to tones. VNS is approved by the FDA and has been used to treat over 60,000 patients for epilepsy and depression, but has not yet been evaluated for safety or efficacy to treat tinnitus.  The device is fully implantable and can easily be used at home. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation, which activate the vagus nerve.  UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”

Continue reading→