Stimpod NMS460 by Xavant Receives FDA Approval

PRETORIA, South Africa, Aug. 1, 2017 /PRNewswire/ — Xavant Technology (Pty) Ltd today announced that the U.S. Food and Drug Administration (FDA) cleared their Stimpod NMS460. With the U.S. patent awarded on proprietary hybrid pulsed radio frequency (PRF) waveform, this non-invasive neuromodulation device is focused on the symptomatic relief and management of chronic intractable pain, as well as an adjunctive treatment in the management of post-surgical pain, post-traumatic acute pain problems, and an adjunct for pain control due to rehabilitation.

The need for this device is profound. More than 100 million Americans report that they have a problem with pain.[1] Chronic pain is characterized by neuroplastic changes that cause sensitization of the nervous system. These changes result in anatomical and physiological changes that affect neurological function, which causes long-term potentiation and gene expression changes that then allow the pain to continue with or without further peripheral input, and a lower pain threshold; this dysfunction then also accounts for the epiphenomena associated with the disease, including emotional, memory, and motor changes, which then becomes the illness of chronic pain.[2]

Treatment of chronic pain in the United States is estimated to cost $600 billion annually.[3] The current standard of care for chronic pain includes drug cocktails such as Corticosteroids, Opiate pain relievers, injections, and beyond combined with treatments like physical therapy and counseling. Treatments can come with various short-term and long-term side effects.

The Stimpod NMS460, however, will greatly impact the industry as a non-invasive, non-drug solution with zero side effects and a fast onset of effect at a fraction of the cost of comparable treatments. The device applies its patented PRF waveform to the affected area transcutaneously. This waveform creates electromagnetic effects similar to invasive pulsed radio frequency treatments, and several case studies have shown instant and dramatic relief of chronic intractable pain. The Stimpod NMS460 also incorporates the nerve-locating technology which features a nerve mapping probe that enables practitioners to locate nerves and evaluate the treatment progress of damaged nerves. Bell Medical has been selected as the master distributor for both the U.S. and Canada.

“We are thrilled at the news that our revolutionary device can now be used in the U.S.,” said Corlius Birkill, CEO of Xavant Technology (Pty) Ltd. “This groundbreaking technology has the ability to help tens if not hundreds of millions of people just in the U.S. as a valuable treatment asset for neurologists, chiropractors, acupuncturists, physical therapists, physiatrists, and medical pain practitioners.”

About Xavant Technology (Pty) Ltd
Xavant Technology (Pty) Ltd is a leading supplier of nerve stimulators for regional and general anesthesia applications. The current Stimpod range has three models – the NMS410, NMS450 and NMS460. The Stimpod NMS460 is a neuromodulation device used for symptomatic relief of chronic intractable pain, implementing a unique patented Pulsed Radio Frequency waveform for the treatment of neuropathies. The Stimpod NMS410 model is a specialized nerve locating device, with its unique nerve mapping and locating cable, used primarily during Regional Anesthesia procedures. The Stimpod NMS450 adds the option to monitor neuromuscular blocking agents with its advanced three-dimensional accelerometer. Learn More About STIMPODNMS460 at http://www.stimpodnms460.com.

Media Contact:
Lourie Höll
Phone: +27 12 743 5959
Email: [email protected]

[1] Gaskin, Darrell J., and Patrick Richard. “The Economic Costs of Pain in the United States.” The Journal of Pain: Official Journal of the American Pain Society (2012): 715-24. Web. 21 June 2017.

[2] American Academy Of Pain Medicine. Neuropathic Pain Recognized as a Disease. N.p.: American Medical Association, 27 Sept. 2016. PDF. https://assets.ama-assn.org/sub/meeting/documents/i16-resolution-912.pdf

[3] Gaskin, Darrell J., and Patrick Richard. “The Economic Costs of Pain in the United States.” The Journal of Pain: Official Journal of the American Pain Society (2012): 715-24. Web. 21 June 2017.

Source: PR Newswire

TOF Watch Discontinued! Stimpod NMS 450 available NOW!

The German manufacturer, MIPM – Mammendorfer Institut für Physik und Medizin GmbH has announced that effective June 30, 2016 the TOF Watch, TOF Watch S and TOF Watch SX neuromuscular monitors will no longer be manufactured.  The official announcement of the discontinuance of the TOF Watch is below:

TOF-Watch – objective neuromuscular monitoring
Product cancelation Note
We wish to inform you that the TOF Watch monitors are not produced and sold any more effective July 1st 2016.

Their USA distributor Blue Star Enterprises will continue selling the TOF Watch while supplies last. They will also offer the replacement alternative from Bell Medical and Xavant called the Stimpod NMS 450. The only accelerometer based neuromuscular monitor now available is the Stimpod NMS 450 from Xavant distributed in the USA and Canada by Bell Medical Inc. The Stimpod NMS 450 is a neuromuscular monitor that offers Quantitative TOF Monitoring as endorsed by the Anesthesia Patient Safety Foundation or APSF.

Stimpod NMS 450 Nerve Stimulator and TOF Monitor

Stimpod NMS 450The Stimpod NMS 450 Nerve Stimulator and TOF Monitor includes a Tri-axial accelerometer which provides real time feedback of the strength of contraction of the affected limb (Train Of Four, Double Burst and Post Tetanic Count modes). The strength of each measured contraction is displayed graphically and the relevant ratios are calculated and also displayed.

The fine movement differences that can be detected by utilizing accelerometry offer major advantages over gauging contraction strength visually or tactilely.

Tri-axial accelerometry calculates the movement vector of the contraction in three dimensions. This negates the need for calibration as is the case with one-dimensional accelerometers, and reduces the setup time of the procedure.

Combined Nerve Mapping and Nerve Location

Auto sensing technology provides a solution for simultaneous nerve mapping and nerve location. The Stimpod monitors whether the mapping probe or needle touches the patient and adjusts the current range accordingly, ensuring quick and precise nerve location.

The Stimpod Nerve Mapping Probe was designed to enable transcutaneous nerve mapping at higher currents (to a maximum of 20mA), whilst the tip offers a contact surface small enough to ensure effective discrimination.

Current Range Load Impedance Stimulating Modes
Nerve Locating: 0.0 – 5.0mA
Nerve Mapping: 0 – 20mA
NMBA Monitoring: 0 – 80mA
Nerve Locating: 0 – 20kΩ (100V)
Nerve Mapping: 0 – 20kΩ (400V)
NMBA Monitoring: 0 -5kΩ (400V)
Train-of-Four (TOF)
Double Burst (DB)
Post-Tetanic-Count (PTC)
Tetanus (TET)
Twitch (1Hz, 2Hz, 5Hz)

Kit includes:

  • STIMPOD NMS450
  • NMBA Monitoring Cable
  • Nerve Locating Cable
  • Nerve Mapping/Locating Cable
  • Carrying Case

Stimpod NMS 450 Comparison Study

TOF Watch (discontinued) STIMPOD NMS450
NMBA Monitoring (Objective) Yes – 1 Dimensional Accelerometer Yes – 3 Dimensional Accelerometer, enhanced accuracy
Calibration Before TOF Monitoring Yes No, easier setup and operation
Nerve Mapping No Yes – Integrated StimPen results in superior nerve blocks
Nerve Block Application Yes Yes
Pulse Width Selections 0.04ms, 0.2ms 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms
Current Range Nerve Locating 0.0 – 6.0 mA
Nerve Mapping None
NMBA Monitoring 0 – 60 mA
Nerve Locating 0.0 – 5.0 mA
Nerve Mapping 0 – 20 mA
NMBA Monitoring 0 – 80 mA
Adjustable Timers Yes Yes
Auto Sensing Technology Yes Yes – Combination Cable Auto Sensing
Warranty Limited One Year Warranty Two Year Warranty
TOF Bar Graph Display No Yes
Lead Wire Construction 18 Gauge OD, thin and fragile 12 Gauge OD, thick and heavy duty, easy thumb application, 6 month cable warranty
Lead Wire & Accelerometer Cable Replacement Cost $296 $260, 12% savings
Device Attachment IV Pole Attachment Drape clip or IV pole option