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)

Biotronik study reveals utility of remote monitoring and remote programming in SCS

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

Image Credit: Biotronik

In 2023 Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System to treat chronic, intractable pain. 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.

A new study using the Prospera® SCS system was published in Neuromodulation supporting the adoption of real-time remote monitoring as a new standard for long-term SCS device management.

According to the press release, the study demonstrates that:

“…automatic, daily remote monitoring of spinal cord stimulation (SCS) devices enables the first real-time visibility into post-implant therapy use, including the identification of “virtual explants” — patients with prolonged device inactivity who have not undergone surgical removal. In the study, patients using the Prospera® SCS system — the only SCS device with automatic, objective, daily remote monitoring and remote programing — maintained high rates of therapy use and low explant rates.”

 

 

 

Boston Scientific acquires Nalu for $533M

Posted on by Posted in Boston Scientific, 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) system, which 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.

On October 17 Boston Scientific announced it has entered into a definitive agreement to acquire Nalu Medical, Inc. for an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific (which has been a strategic investor since 2017).

 

Biotronik presents 24-month interim data from the BENEFIT-03 clinical study at NANS

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

Image Credit: Biotronik

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.

This weekend at NANS 2025 Biotronik presented  24-month intermediate data from its BENEFIT-03 prospective, multicenter clinical study in Australia.  Continue reading→

Neuronoff’s Injectrode Transcutaneously-Powered Nerve Stimulation

Posted on by Posted in Neural Stimulation, Neuronoff, Pain, PNS, Spinal Cord Stimulation
Neuronoff Injectrode

Image Credit: Neuronoff

Some time ago, I posted about Bioness’ “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. Unlike most externally-powered neurostimulators this device is not powered by RF received from the external transmitter. Instead, the external pulse transmitter is more like a TENS unit with gelled electrodes applied to the skin. The implant has no electronic components. It is just a lead that has a coil electrode that intercepts part of the current between the TENS electrodes, and routes the captured current to small electrodes in contact with the target nerve at the distal end of the lead.

A similar approach is now being trialed under an IDE by Cleveland-based Neuronoff, Inc.  Their “Injectrode” approach consists of an implanted lead that is injected via an 18 ga needle injection.  The lead is activated transcutaneously with an external stimulator. 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→

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→