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

Category Archives: Pain

Implantable devices for treating pain (spinal cord stimulators and others)

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→

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→

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.

 

Taiwan’s Gimer Medical 500 kHz NeuroBlock SCS

Posted on by Posted in GimerMedical, Pain, Spinal Cord Stimulation

Image Credit: Gimer Medical

Gimer Medical is a Taiwanese medical device manufacturer founded in 2013.  It set up the first implantable electronics factory in Taiwan in 2018.

Gimer’s NeuroBlock spinal cord stimulation (SCS) system is based on technology developed at the Taiwan National University in 2008 combining pulsed radio frequency (PRF) with SCS into the so-called “+RF” technology – an ultra-high frequency of 500 kHz, which Gimer claims has a high penetration rate, no heat sensation during the treatment, no protein denature, and no action potential changes.  It is expected to produce paresthesia-free and prolonged treatment effect for chronic pain patients.

On August 13, 2022, the US FDA granted conditional Investigational Device Exemption (IDE) approval to Gimer to trial the NeuroBlock SCS system.

Nevro Announced 5% Workforce Layoffs As Part of Restructuring

Posted on by Posted in AIMD Business, Nevro, Pain, Spinal Cord Stimulation

Image Credit: Nevro

As part of its Q4 2023 results, Nevro announced that it plans to lay off approximately 5% of its internally-facing workforce to increase its 2024 earnings by $14 million to $15 million.

This news comes after Nevro announced at the end of November 2023 that it acquired Vyrsa Technologies for $40 million cash plus up to an additional $35 million based on milestones.  Vyrsa manufactures a spinal-fusion device for patients suffering from chronic sacroiliac joint (“SI Joint”) pain.

Nevro’s Q4 2023 worldwide $116.0 million revenue exceeded Company’s expectations (2% growth as reported and 1% constant currency compared with Q4 2022).  Its full-year 2023 worldwide revenue was approximately $425.0 million, representing 5% growth reported and 4.5% on a constant currency basis.

Biotronik Receives FDA Approval for Prospera SCS System (March 2023)

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera SCS

Image Credit: Biotronik (from FDA’s PMA approval)

Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System on March 31, 2023.  The system is intended to treat chronic, intractable pain in the trunk or limbs.

The Prospera SCS System includes a rechargeable IPG, SCS leads, a clinician programmer, a patient programmer, and an external trial pulse generator.

The system features connectivity with Biotronik’s Embrace One™, which the company claims to provide automatic, objective, remote daily data transmission for true proactive care management.

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→

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

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.

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.”

Nevro Receives CE Mark for Senza® Omnia™ Spinal Cord Stimulation System to Treat Chronic Pain

Posted on by Posted in Nevro, Pain, Spinal Cord Stimulation

Image Credit: Nevro

Nevro announced it has received CE mark approval for the Senza® Omnia™ Spinal Cord Stimulation (SCS) system.  According to the announcement:

“The Omnia system is a completely new SCS platform and consists of a number of new components. The first is the new Omnia programmer, which will allow physicians to easily offer the widest array of waveforms across the full SCS frequency spectrum, either separately or paired together with HF10.  The second element of the system is a redesigned patient remote that is more intuitive for patients to use.  The new remote supports greater programming capacity, allowing for the flexibility to expand on the HF10 algorithm by giving physicians the ability to provide additional waveforms.  The third component is a redesigned, slimmer patient charger with an improved user interface.  Lastly, the system comes with an updated and upgradeable implantable pulse generator.  Unlike non-rechargeable systems, the Omnia battery is designed to last over ten years no matter what stimulation profile is used, has conditional full body MRI approval, and will be upgradeable to future waveforms and frequencies.”

Continue reading→

SCS Companies Developing “Low Dose” Recharge-Free Spinal Cord Stimulation Devices

Posted on by Posted in Abbott, Pain, Spinal Cord Stimulation

Image Credit: Abbott

Spinal Cord Stimulation uses quite a bit of power, which is why SCS IPGs have either been rechargeable, or operated from a primary cell, but compromised on longevity.

Because recharging is sometimes perceived by patients as a hassle, SCS companies have been developing and testing “low-dose” stimulation regimens with the intention of yielding high-longevity SCS IPGs that don’t require recharging.

In September 2019 FDA approved Abbott’s Proclaim™ XR neurostimulation system which uses Abbott’s proprietary, low energy BurstDR™ therapy coupled with the BoldXR™ low dosing protocol for safe, effective pain relief and a battery that lasts up to 10 Years (at low-dose settings).

Approval was based on the results of the “BurstDR micrOdosing stimuLation in De-novo” patients (BOLD) study, which showed 100% of 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). Even at the highest settings, the systems were still in use only 25% of the time.