---
title: "The Week in Neuromodulation: New Clinical Trials and Devices"
description: Following is a sampling of Neuromodulation segment updates from the past week that were compiled and posted throughout the day in real-time by the analysts at SmartTRAK...
---

[Medical Device and Wound Care News and Analysis Blog ](https://blog.smarttrak.com)

# [The Week in Neuromodulation: New Clinical Trials and Devices](https://blog.smarttrak.com/the-week-in-neuromodulation)

 Written by [Thomas Wallick](https://blog.smarttrak.com/author/thomas-wallick) | 6/23/20 12:30 PM

This week, our expert analysts have sifted through the noise to present some of the latest product developments and clinical trials from the Neuromodulation industry. At **SmartTRAK,  **our analysts constantly monitor the worldwide MedTech industry to present real-time news, analysis and financial data. All of our analysts are experts in their field, having worked in business development, marketing and competitive intelligence roles at leading medical device companies.

The following is a small sampling of Neuromodulation segment updates from the past week that were compiled, reviewed and posted throughout the day by the industry-experienced analysts at **SmartTRAK**:

**Mainstay Medical Receives FDA Approval for ReActiv8 System**

Mainstay Medical rec’d FDA approval 6/16/20 for the ReActiv8 System indicated for stimulation of the L2 medial branch of the dorsal ramus for intractable CLBP assoc. w/ multifidus muscle dysfunction. Chris Gilligan, *MD-INS Webinar: Novel Stimulation Technologies-Recent Research.*

**Non-Invasive VNS for PTSD and Mild TBI**

The VA is sponsoring a 100-pt, double-blinded study [evaluating](https://clinicaltrials.gov/ct2/show/NCT04437498?sfpd_s=06%2F16%2F2020&sfpd_d=2) the effect of non-invasive VNS (nVNS) vs sham on memory and symptoms of PTSD and mild TBI (mTBI) as well as brain and physiology in veterans w/ mTBI and PTSD. The study starts 8/1/2020. clinicaltrials.gov

**Rice-Sized Neural Stimulator for DBS**

Rice University researchers [demonstrated](https://www.cell.com/neuron/pdf/S0896-6273(20)30365-2.pdf?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS0896627320303652%3Fshowall%3Dtrue) that a miniature, wireless magnetically powered neural stimulator (> 100 Hz) can [provide](https://news.rice.edu/2020/06/08/rice-team-makes-tiny-magnetically-powered-neural-stimulator-2/) DBS in a rodent model for Parkinson’s disease and that these devices can be miniaturized to millimeter-scale and fully implanted. Neuron

**[Nevro](https://app.smarttrak.com/companies/qs/73318)**

E Petersen [presented](https://diabetes.diabetesjournals.org/content/69/Supplement_1/31-LB) 3-mo results from the 213-pt SENZA-PDN study in a late-breaking poster session at the virtual ADA annual mtg. In the 10 kHz SCS +CMM group (N=113), the VAS [dropped](https://diabetes.diabetesjournals.org/content/diabetes/69/Supplement_1/31-LB/F1.large.jpg) from 7.6 to 1.7 at 3 mos vs a decrease from 7.0 to 6.5 in the CMM group (N=103). *Poster 31-LB*

**Neuromodulation of Vagal and Carotid Sinus Nerves **

LivaNova’s US Patent Application “NEUROMODULATION THERAPY FOR AUTO-IMMUNE AND INFLAMMATORY DISORDERS” was [published](http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220200188671%22.PGNR.&OS=DN/20200188671&RS=DN/20200188671) re stimulating multiple locations (VNS, carotid sinus nerve) to treat inflammation, sleep quality issues and symptoms of cardiovascular disease. 20200188671

**Combined Spinal Fixation and Neuromodulation Procedure**

SynerFuse Inc was [issued](http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10675458.PN.&OS=PN/10675458&RS=PN/10675458) US Patent “Methods and systems for implanting a neuromodulation system and a spinal fixation system at a surgically open spinal treatment site” re treating both back stabilization issues and neuropathic pain issues in a single procedure. *10,675,458*

**[Senza Omnia SCS](https://app.smarttrak.com/products/qs/411280bc42cb6a81ac1002a7fddd013b) - [Nevro](https://app.smarttrak.com/companies/qs/73318)**

Nevro [announced](https://www.nevro.com/English/us/investors/investor-news/investor-news-details/2020/Nevro-Announces-TGA-Approval-and-July-1st-Prostheses-Listing-of-Senza-Omnia-Spinal-Cord-Stimulation-System-/default.aspx) the Company received TGA approval and upcoming July 1, 2020 Prosthesis Listing for the Senza Omnia SCS System, allowing the Company to launch the device in Australia.

**Axonics Modulation Technologies**

Axonics Modulation Technologies was [issued](http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10682521.PN.&OS=PN/10682521&RS=PN/10682521) US Patent “Attachment devices and associated methods of use with a nerve stimulation charging device” related to affixing a portable charging device to the skin of a pt to align over an IMD to facilitate charging. *10,682,521*

**Temporally Optimized Patterned DBS**

A 36-pt, randomized, crossover study sponsored by Deep Brain Innovations is [evaluating](https://clinicaltrials.gov/ct2/show/NCT04390867) new Temporally Optimized Patterned Stimulation (TOPS) in implanted DBS pts to determine if it improve Parkinson’s symptoms vs standard DBS. The study starts in 6/2020. *clinicaltrials.gov*

**Effect of Peripheral Neuromodulation on Vaginal Blood Flow** 

A 40-pt, randomized, crossover study is [evaluating](https://clinicaltrials.gov/ct2/show/NCT04384172) the effect of tibial e-stim followed by genital e-stim on vaginal blood flow compared btwn women w/ neurogenic (SCI) or non-neurogenic sexual dysfunction and healthy women. The study starts in August 2020. *clinicaltrials.gov*

**Micron Medical Appoints New CMO**

Micron Medical [appointed](https://markets.businessinsider.com/news/stocks/micron-medical-appoints-seasoned-urology-executive-matthew-kemp-as-chief-commercial-officer-1029308357) Matthew Kemp as CMO. Kemp will be responsible for building Micron’s commercial organization to support the intro/launch of its Protect PNS, an implantable, office-based, TNS for OAB. Prior to joining Micron, Kemp was CMO at PolarityTE and Dendreon.

SmartTRAK is a comprehensive, easy-to-use, business intelligence solution for the Life Sciences Industry that provides breaking updates on pertinent company news, potential treatments and guidance, international survey results, statistical analysis and impact by country, studies, trial results, financial impact and more. All subscribers receive a Daily Updates email containing the latest need-to-know news curated by our expert analysts. It's the perfect way to start your day! If you would like to learn more about **SmartTRAK**, just [click](https://www.smarttrak.com/covid-19-coverage) the button below.

[View full post](https://blog.smarttrak.com/the-week-in-neuromodulation)

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