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

Category Archives: Nevro

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.

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.

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 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]

 

 

 

Nevro Receives FDA Approval to Initiate Trial of its High-Frequency Spinal Cord Stimulation Therapy

Posted on by Posted in Nerve Blocking, Neural Stimulation, Nevro, Pain, Spinal Cord Stimulation
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain

Image Source: Nevro's Website

Nevro Corp announced that FDA has granted approval for initiation of its SENZA-RCT study, a U.S. prospective, randomized, controlled pivotal clinical trial evaluating the safety and efficacy of Nevro’s high-frequency spinal cord stimulation system for the treatment of chronic pain.

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Nevro’s Senza Rechargeable Spinal Cord Stimulator for Back and Leg Pain

Posted on by Posted in Nevro, Pain, Spinal Cord Stimulation, Wireless Power Transmission
Nevro Senza Implantable Spinal Cord Stimulator for Back and Leg Pain
Image Source: Nevro’s Website

Nevro Corporation (formerly NBI Development) was founded in 2006 by Dr. Konstantinos Alataris.  The Menlo Park, CA company developed a pain management concept that originated at the Mayo Clinic into a spinal cord stimulation system for back and leg pain.

According to Nevro, their unique stimulation waveform achieves pain relief without paresthesia or uncomfortable stimulation.  Few details are available about the waveform, but Nevro’s Spanish distributor’s brochure specifies it as high-frequency stimulation at 10,000 Hz.  This is consistent with Nevro’s patent applications which teach that “high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient’s spinal cord region to address low back pain without creating unwanted sensory and/or motor side affects.” Continue reading→