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

Category Archives: Spinal Cord Stimulation

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.”

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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.

 

SCS Company Nuvectra Filed for Bankruptcy

Posted on by Posted in CCC Medical, Greatbatch, Integer, Nevro, Nuvectra, Pain, Spinal Cord Stimulation

Image Credit: Nuvectra

Back in 2013, implantable-grade component manufacturer Greatbatch Medical (now Integer Holdings) briefly entered the finished devices market with its own Algostim Spinal Cord Stimulator.

However, when Greatbatch acquired CCC Medical in 2014, having the Algostim SCS was seen as a conflict of interest by some of CCC’s SCS customers (e.g. Nevro), so in 2015/2016 Greatbatch divested its SCS business into a new company called Nuvectra.

Nuvectra never caused much of an impact in the SCS market, and trailed well behind Abbott, Boston Scientific, Medtronic, and Nevro.  After limping along for a number of years, on November 12, 2019, Nuvectra filed for Chapter 11 bankruptcy.

James Cavuoto, Editor and Publisher of Neurotech Reports, wrote about possible reasons for Nuvectra’s failure:

“… Some critics of Nuvectra have cited management problems and quality control issues with its Algovita device as factors leading to the filing. Fred Parks, a medical device industry veteran with little experience in the SCS market, took over for founding CEO Scott Drees in January. Others have pointed to problems managing the company’s suppliers and an overly burdensome agreement Greatbatch required as part of the spinoff. …” [2019]

 

 

 

Bioness StimRouter CE-Marked to Treat Fecal Incontinence

Posted on by Posted in Bioness, Incontinence, Sacral Root Stimulation, Spinal Cord Stimulation

Image Credit: Bioness

Bioness announced that its StimRouter received the CE-Mark to Treat Fecal Incontinence.

Unlike most externally-powered neurostimulators, the StimRouter 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. Continue reading→

GTX and NeuroRecovery Technologies Merge

Posted on by Posted in GTX Medical, Spinal Cord Injury (SCI), Spinal Cord Stimulation

Image Credit: GTX Medical

GTX Medical of The Netherlands and Switzerland, and NeuroRecovery Technologies, of San Juan Capistrano, California announced they intend to merge as GTX Medical with the goal of developing devices for restoring movement and the ability to walk in patients with paralysis and spinal cord injuries.

Shareholders and investors include the  Christopher and Dana Reeve Foundation, LSP, Inkef, Wellington Partners, and GIMV.

The joint company will focus on developing two technologies to improve the functional recovery of people with spinal cord injuries:

  1. Targeted Epidural Spine Stimulation (TESS) – an implantable spinal cord stimulation system with real-time motion feedback
  2. Transcutaneous Spinal Cord Stimulation (tSCS) – a noninvasive device aimed at restoring upper limb movement and hand function

Medtronic Q1 FY2020: Cardiac Rhythm & Heart Failure Down 3.1%, Pain Therapies Down 7%

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Medtronic, Neural Stimulation, Pain, Spinal Cord Stimulation, Tachycardia, Uncategorized

Medtronic announced today its financial results for its first quarter of fiscal year 2020.  As a whole, the company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent.

However, Cardiac Rhythm & Heart Failure decreased 3.1 percent as reported (1.2 percent on a constant currency basis).   According to the press release”

“Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra® transcatheter pacing system, as well as mid-thirties growth of the TYRX® absorbable antibacterial envelope, high-single digit growth of the Reveal LINQTM insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.”

Pain Therapies, the other area of Medtronic’s business that depends heavily on active implantable medical devices also took a hit, with first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis.   The announcement explains:

“Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.”

 

Bioness’ StimRouter Implantable Neurostimulator Reroutes TENS Pulses

Posted on by Posted in Bioness, Pain, PNS, Sacral Root Stimulation, Spinal Cord Stimulation, Wireless Power Transmission

Bioness' StimRouter implantable neurostimulator. www.implantable-device.com David Prutchi PhD

Bioness is a Valencia, California medical device/rehabilitation company founded by the late Alfred Mann some 15 years ago. He had previously acquired a miniature stimulator called the BION, and a company called NESS who had a footdrop stimulator. The combination of the two is where the name Bioness came from.

One of its products is the “StimRouter”, which is an externally-powered implantable peripheral nerve stimulator designed to reduce chronic pain. It gained FDA approval in 2015 and was launched in mid-2016.

Unlike most externally-powered neurostimulators however, the StimRouter 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.

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WEL Neuci-3M – An Ukrainian Neurostimulator for Nerve Regrowth

Posted on by Posted in Pain, Paralysis, Spinal Cord Stimulation, WEL (Kiev)

Neuci-3M by WEL

I was recently invited to visit a company in Kiev, Ukraine which manufactures implantable neurostimulators intended to cause nerve regrowth after spinal-cord or peripheral-nerve injury.

WEL was founded in 1993 for the development and production of electronics and microelectronics products. Its design and manufacturing facilities are located within a Soviet-era microelectronics manufacturing complex that is now largely abandoned.

WEL’s bread-and-butter is the production of industrial power control systems, but got into the medical implantables business after a request from a local hospital treating spinal-cord injury war casualties.

WEL’s main neurostimulator system is the “Neuci-3M” two-channel, externally RF-powered system. The implant is a simple two-frequency passive receiver potted in epoxy and overmolded with silicone rubber. The external transmitter is responsible for controlling all stimulation parameters. WEL also produces their own leads, including one with “petal” electrodes specifically for the stimulation of nerve regrowth.

WEL’s homepage is at: http://www.wel.net.ua/  They don’t have an English webpage, but Google translate does pretty well when viewing the page through Chrome.

Clinical work with this neurostimulator is conducted mainly by the Academician A. P. Romodanov Institute of Neurosurgery of the Academy of Medical Sciences of Ukraine.

Saluda Medical’s Closed-Loop Evoke SCS Device for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Image credit: Saluda Medical

Back in 2013 I reported that Sydney, Australia-based Saluda Medical had started the development of a closed-loop SCS system for pain.

Since then, Saluda has gone through a number of financing rounds, the latest being all-equity $40M from Action Potential Venture Capital (APVC, a GSK fund that invests in companies developing bioelectronic medicines) and Medtronic.

Saluda’s rechargeable Evoke Spinal Cord Stimulator is meant to detect the neural signals evoked by the stimulation system to maintain effective stimulation levels. The idea is that based on the evoked-potential feedback, as well as its knowledge of the user’s preferences, will allow the system to personalize therapy for optimal response against pain.

Saluda has presented long-term clinical data from its first chronic implant study, which was conducted in Australia. According to the presented results, at 6 months, subjects with axial back pain experienced an average sustained improvement of 80% relief. In addition, the 32-patient cohort showed clinically meaningful improvements in function, disability, and sleep.

Saluda Medical’s website: https://www.saludamedical.com

St. Jude’s Protégé Upgradeable Neurostimulator Receives FDA Approval

Posted on by Posted in Pain, Spinal Cord Stimulation, St. Jude Medical

St. Jude Protege Neurostimulator www.implantable-device.com David Prutchi PhD

St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates.  According to the press release:

Chronic pain sufferers implanted with this new device can access innovative therapies, stimulation modes, diagnostics or other features once approved through future software upgrades — without the need to surgically replace their medical device.

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Boston Scientific Reports Good Results with Precision Spectra™ SCS

Posted on by Posted in Boston Scientific, Pain, Spinal Cord Stimulation

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com David Prutchi, Ph.D.

Retrospective data for Boston Scientific’s Precision Spectra™ Spinal Cord Stimulator (SCS) System were presented at the North American Neuromodulation Society (NANS) 17th annual meeting in Las Vegas. The data show that the device provided highly significant pain relief three months after implantation.

According to the press release:

Precision Spectra is the first SCS System designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. By providing 32 contacts – twice the number of contacts available with other SCS systems – the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain.

The retrospective study of up to 213 consecutive patients at 13 centers focused on patients with chronic pain who were treated with the Precision Spectra SCS System. Results include:

A 94 percent SCS trial therapy success rate (n=213)

A highly significant reduction in pain from an average baseline score of 7.8, on a 10-point scale, to an average score of 3.2 at three months post implant (in the patients who have reached the three-month follow up, n=113)

A highly significant reduction in low back pain from an average baseline score of 7.0, on a 10-point scale, to an average of 2.9 at three months post implant (in the low back pain patients who have reached the three-month follow up, n=32)

Early results indicate improvements in function, including walking and sleeping, in addition to reductions in opioid use and disability

St. Jude Studies Combined PNFS and SCS for Chronic Low Back and Leg Pain

Posted on by Posted in Pain, PNS, Spinal Cord Stimulation, St. Jude Medical

St Jude Medical Eon and Eon Mini Spinal Cord Stimulators

St. Jude announced today that it has launched the SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study – a clinical study to evaluate the combination of peripheral nerve field stimulation (PNfS), and spinal cord stimulation (SCS), to determine whether the two therapies together offer more effective management of chronic low back and leg pain than SCS alone.

According to the press release:

Peripheral nerve field stimulation and SCS are minimally-invasive neurostimulation therapies that involve the implant of a stimulation device and small electrical leads. In SCS, leads are placed in the epidural space to interrupt or mask the transmission of pain signals to the brain. In PNfS, leads are placed just under the skin in the subcutaneous tissue to stimulate the network of peripheral nerve fibers in order to reduce the pain at the location where it is most severe. PNfS is not the same as peripheral nerve stimulation (PNS), which targets a specific nerve. Instead, PNfS targets a more general network of nerves.

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St. Jude Launches SUNBURST Study to Evaluate New Prodigy Neurostimulator’s Burst Stimulation for Chronic Pain

Posted on by Posted in Pain, Spinal Cord Stimulation, St. Jude Medical

St Jude Prodigy Neurostimulator Burst David Prutchi PhD www.implantable-device.comSt. Jude announced today that it has initiated a clinical study of the Prodigy™ neurostimulator, which is the first SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation.

The purpose of the SUNBURST™ (Success Using Neuromodulation with BURST) study is to evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

According to the press release:

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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).

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