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

Saluda’s Evoke Spinal Cord Stimulation Received FDA Approval (Feb 2022)

Posted on by Posted in Neural Stimulation, Pain, Saluda Medical, Spinal Cord Stimulation
Saluda Medical Evoke IPG

Image Credit: Saluda Medical

In February 2022 FDA approved Saluds Medical’s Evoke® Spinal Cord Stimulation (SCS) System (Evoke System), which is an implanted, rechargeable spinal cord stimulation system intended to treat chronic, intractable pain in the trunk or limbs.

The Evoke® System automatically adjusts stimulation to maintain precise and consistent neural activation with breathing, coughing, positional changes and activity to keep a patient at their prescribed stimulation dose. Continue reading→

BlueWind Medical’s Revi System Tibial Neuromodulation System Approved by FDA

Posted on by Posted in Bluewind Medical, Incontinence, Neural Stimulation, Tibial Nerve Stimulation

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.

Continue reading→

Axonix Receives FDA Approval for F15 Stimulator for Treating Bladder and Bowel Dysfunction

Posted on by Posted in Axonics, Bowel Discfunction, Incontinence, Sacral Root Stimulation

 

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.

 

LivaNova starts clinical trial on ImThera’s device for Obstructive Sleep Apnea

Posted on by Posted in Hypoglossal Neurostimulation, ImThera Medical, LivaNova, Obstructive Sleep Apnea
ImThera IPG

Image Credit: LivaNova

In December 2017, LivaNova acquired San Diego-based ImThera – a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (“OSA”).

The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically‐placed multi‐contact electrode specifically designed for the Hypoglossal nerve, and a lead that connects the electrode to a programmable, rechargeable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.

In March 2022, LivaNova announced that it had implanted the first patient with an InThera aura6000 in the “OSPREY” “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” IDE trial

Medtronic Receives FDA Approval for Interstim X™ for Bowel and Bladder Control

Posted on by Posted in Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation

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.

What Happens to Patients when AIMD Company Vanishes? IEEE Damning Report of Second Sight

Posted on by Posted in Blindness, Retinal Stimulation, Second Sight
Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

Image Credit: Second Sight

IEEE published a damning report on Second Sight’s lack of support for patients who were implanted with their Argus and Argus II retinal prostheses.  It is unfortunate that investors and creditors are placed in font of patients who act as subjects to advance our Industry.  As the IEEE report puts it:

“After Second Sight discontinued its retinal implant in 2019 and nearly went out of business in 2020, a public offering in June 2021 raised US $57.5 million at $5 per share. The company promised to focus on its ongoing clinical trial of a brain implant, called Orion, that also provides artificial vision. But its stock price plunged to around $1.50, and in February 2022, just before this article was published, the company announced a proposed merger with an early-stage biopharmaceutical company called Nano Precision Medical (NPM). None of Second Sight’s executives will be on the leadership team of the new company, which will focus on developing NPM’s novel implant for drug delivery.”

This is not the first time that the fate and interest of patients have been been placed behind that of investors and creditors.  James Cavuoto, the Editor of Neurotech Reports proposed solutions a few years ago after a number of neurostim companies closed their doors:

‘Bankruptcy courts should put implanted patients high on the priority list of creditors. Firms or institutions that volunteer to support existing patients should get IP priority on any technology that was used. And the government should underwrite funds needed for ongoing care of orphaned patients. We owe it to patients to live up to the adage, “Do no harm.” ‘

 

 

FDA Panel Rejects BrainsGate’s Spheno-Palatine Ganglion Stimulator to Treat Ischemic Stroke

Posted on by Posted in Brainsgate, Ischemic Stroke, Sphenopalatine Ganglion Stimulation, Yossi Gross (Rainbow Medical)

Image Credit: BrainsGate

BrainsGate is an Israeli company that was established in 2000.  It developed an implantable device for the stimulation of the Spheno-Palatine Ganglion (SPG) to modulate the brain-blood barrier and increase cerebral blood flow.

On December 10, 2021, BrainsGate’s clinical study was discussed by an FDA panel, which although agreed on the safety of the system, did not find the device sufficiently effective as a treatment for stroke, whereby its benefits would outweigh the risks.

The voting was:

  • Safety:  13 votes in favor
  • Effectiveness: 3 votes in favor, 7 against, 3 abstain
  • Benefits outweigh risk: 3 votes in favor, 7 against, 3 abstain

FDA does not have to follow the recommendations of its panels, but it mostly does (approximately 80% of the time), and such low vote of confidence does not bode well for BrainsGate’s SPG stimulation as a treatment for ischemic stroke.

Image Credit: BrainsGate

 

Nalu Externally-Powered Neurostimulation System for SCS and PNS Indications

Posted on by Posted in Nalu, Pain, PNS, Spinal Cord Stimulation

Image Credit: Nalu

Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California.  They developed the Nalu micro-Implantable Pulse Generator (mIPG), which was was named the Implant and Tissue-Replacement device Gold Winner at the 2021 Medical Design Excellence Awards (MDEA).

The Nalu system consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.

Nalu’s website is at: nalumed.com

Neuspera Medical Closes $65M Round to Fund Urinary Urgency Incontinence Trial

Posted on by Posted in AIMD Business, Incontinence, Neuspera, Neuspera Mid Field Powering, Sacral Root Stimulation

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

OT: My New Book on Near-IR Treatment of Brain Disorders is Now Available

Posted on by Posted in Alzheimer's, Brain Stimulation, David Prutchi's Portfolio, Dementia, Depression, Ischemic Stroke, My Portfolio, Opioid Overdose, Stroke

My new book is out and available through Amazon!

High-Power Near-Infrared Light Treatments for Depression, Dementia, and Other Brain Disorders

Light of specific wavelengths and intensities has been shown to repair and protect neurons from damage, opening the possibility of using near-infrared light as a non-invasive treatment of various brain and psychiatric disorders.

This book serves as a practical overview of the scientific fundamentals, technical implementation, and therapeutic applications of transcranial photobiomodulation:

  • Part I provides an accessible explanation of why the irradiation must be done in the near-infrared region of the light spectrum. It presents evidence-based background on the parameters of light important to photobiomodulation, and describes the effects of near-infrared light on cells and tissues.
  • Part II discusses the types of multi-Watt light sources required to non-invasively deliver therapeutic doses of infrared light to the brain. Importantly, this part describes in detail various High-Power Near-Infrared Transcranial Therapy (HIPNITT) medical devices that have been used in clinical trials.
  • Part III presents the potential and challenges of using near-infrared light in the treatment of various brain disorders such as depression, dementia, traumatic brain injury, and Parkinson’s disease.

This book uses straightforward language and offers practical guidance to help readers quickly develop an understanding of the practical aspects of HIPNITT implementation and its therapeutic applications.

Nevro Receives FDA Approval for for High-Frequency SCS Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy (PDN)

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro’s Website

FDA has approved an additional indication of Nevro’s Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).  According to the announcement, “this approval is specific to Nevro’s unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN.  The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.”

Nevro also announced its Q1 2021 revenue to be around $102.3 million, an increase of 81% compared to $56.4 million in the prior year period and an increase of 9% compared to $93.6 million in the second quarter of 2019.  Nevro expects Q2 2021 revenue to be $85.0 million, an increase of 67% compared to $51.0 million in the prior year period and an increase of 9% compared to $78.1 in the second quarter of 2019.

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

 

CVRx Files Intention to IPO with SEC

Posted on by Posted in AIMD Business, Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

Back in August of 2019, Minneapolis-based CVRx received a no-panel FDA approval for its BAROSTIM NEO™ device to treat Heart Failure.  CVRx has now filed documents with the SEC with plans to offer 6.25 million shares of common stock priced between $15 and $17 per share, expecting to yield approximately $91.5 million in the offering.

The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors.  The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.

CVRx’s system  is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.

CVRx website:  www.cvrx.com

UPDATE: June 30, 2021, 2:49 pm

Yesterday CVRx upsized its IPO of 7M shares of its common stock at a public offering price of $18 per share.  Trading started today and share price was $27 mid-afternoon.

UPDATE: July 9, 2021, 2:09 pm

A week after IPO CVRx’s stock has lost all of its initial gains.  It is now trading around the original offering price of $18.

 

 

Update December 13, 2021

And CVRx stock keeps on tanking…

NeuroPace IPO

Posted on by Posted in AIMD Business, Brain Stimulation, Epilepsy, NeuroPace

Image Credit: NeuroPace

NeuroPace of Mountain View, CA  announced last month that it filed with the SEC to raise up to $75 million in an initial public offering. However, the IPO was upsized from the initial expectations, with the company offering 6 million shares of common stock at $17 per share, totaling gross proceeds of $102 million.  It shares began trading on April 21, 2021 on the Nasdaq under the NPCE ticker.

On April 26 NeuroPace announced the closing of its initial public offering of 6,900,000 shares of its common stock, including the exercise in full of the underwriters’ option to purchase 900,000 additional shares of common stock, at the initial public offering price of $17.00 per share. The gross proceeds to NeuroPace, before deducting underwriting discounts and commissions and offering expenses, were approximately $117.3 million.

Shares rose above $24 after the first day of trading, and have remained steady, closing at $25.78 today.

Unlike Cyberonics’ VNS IPGs, the RNS® neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.