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FDA approves Nevro HFX iQ spinal cord stimulation

Senza HFX iQ spinal cord stimulation (SCS) system [Image from Nevro]Nevro (NYSE:NVR) announced that the FDA approved its Senza HFX iQ spinal cord stimulation (SCS) system.

Redwood City, California-based Nevro designed Senza HFX iQ to use artificial intelligence (AI) to learn from patients. The company says it’s the first such SCS system. It utilizes Nevro’s high-frequency 10 kHz therapy platform.

The company developed it to address the variability in pain from patient to patient. This helps to optimize and maintain long-term pain relief and improved quality of life.

Senza HFX iQ features an implantable pulse generator, the HFX trial stimulator, charger and HFX app. Nevro plans to launch it with algorithms specifically for treating chronic back and leg pain. These algorithms cover non-surgical back pain and painful diabetic neuropathy (PDN).

NVR shares were up more than 6% to $38.63 apiece in midday trading today on the news, announced yes…

Nevro wins FDA approval for manufacturing operations in Costa Rica

[Image courtesy of Google Maps]Nevro (NYSE:NVRO) announced that the FDA approved manufacturing operations in Costa Rica for the production of its spinal cord stimulation (SCS) systems.

Redwood City, Californa-based Nevro’s new facility sits in the Coyol Free Trade Zone in Alajuela, Costa Rica. It produces proprietary SCS systems that treat chronic pain, including the HFX product platform.

The facility represents the company’s first global manufacturing operation. Nevro said this ensures greater controls and efficiency while augmenting manufacturing nad supply chain partners.

“We are pleased that the FDA has approved our new global manufacturing operations in Costa Rica,” said D. Keith Grossman, chair, CEO and president of Nevro. “As part of our growth plans moving forward, this manufacturing facility will support our pipeline of future products to ensure that we have the most efficient cost structure and flexible capacity, whi…

Nevro wins multiple coverage options for spinal cord stimulation

The Senza system [image from Nevro]Nevro (NYSE:NVRO) today announced positive updates to multiple spinal cord stimulation (SCS) coverage policies.

Aetna’s new SCS policy explicitly covers PDN (painful diabetic neuropathy), effective Aug. 29, 2022. Aetna’s health plan covers approximately 22 million commercial lives.

Novitas and First Coast, Medicare Administrative Contractors (MACs) that represent 12 states, also provided a positive update. They published draft local coverage determinations (LCDs) that proposed updated coverage criteria to include PDN. This includes PDN refractory to conventional medical management for SCS devices with an explicit FDA approval to treat PDN.

The LCDs — if finalized — mean Medicare patients in all 50 states will receive coverage for PDN. This would add approximately 17 million covered Medicare lives, according to a news release. The review for the proposed LCDs is ongoing with finalization dates yet to be determin…

Boston Scientific to pay Nevro $85M to settle rest of patent litigation

Nevro (NYSE:NVRO) and Boston Scientific (NYSE:BSX) announced today that they reached a settlement over intellectual property litigations.

The settlement gives Boston Scientific the freedom to operate using the features and capabilities embodied in its current line of products for frequencies below 1,500 Hz, with Nevro given the freedom to operate using the features and capabilities in its current line of products. It concludes all existing litigations between the companies and includes a payment of $85 million from Boston Scientific to Nevro.

Nevro had filed a patent infringement suit in the Northern District of California relating to high-frequency paresthesia-free spinal cord stimulation (SCS) therapy. In 2018, Boston Scientific assured the court that it had no imminent plans to commercially launch a high-frequency spinal cord stimulation system delivering therapy at frequencies between 1,500 Hz and 100 kHz and the parties agreed to the dismissal of Nevro’s d…

Nevro touts 12-month data for 10 kHz spinal cord stimulation

Nevro (NYSE:NVRO) announced today that it published 12-month data from the Senza-NSRBP randomized controlled trial.

Redwood City, California-based Nevro’s data, published in Journal of Neurosurgery: Spine, showed that high-frequency 10 kHz spinal cord stimulation (SCS) therapy results in profound improvement in non-surgical refractory back pain (NSRBP) patients in comparison to conventional medical management (CMM).

Outcomes from 121 patients implanted with 10 kHz SCS, including those who crossed over from the CMM arm to 10 kHz therapy, displayed benefits such as 78.2% of participants reporting pain relief, with the average pain relief registering at 72.1% (70.4% in the crossover arm).

The study demonstrated adverse event report rates similar to what has been reported before, including the Senza-RCT, with only three of 145 permanent SCS devices explanted (all due to wound complications) for an explant rate of 2.1%. No explants were performed due to…

FDA approves expanded labeling for Nevro spinal cord stimulation

Nevro (NYSE:NVRO) today said it received FDA approval for expanded labeling of its Senza spinal cord stimulations system to treat non-surgical refractory back pain (NSRBP).

Redwood City, California–based Nevro designed the 10 kHz therapy to improve pain relief and reduce opioid use. The 12-month results from a study of the system showed that patients who received the therapy demonstrated “profound” improvements in pain relief, function, quality of life, awareness of positive change and reduction in daily opioid use compared to conventional medical management at 12-months post-implant, according to the company.

“Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery,” CEO and president Keith Grossman said in a news release. “This FDA approval marks another milestone in Nevro’s commitment to expanding access to 10 kHz Therapy for these unders…

UnitedHealthcare to cover Nevro’s spinal cord stimulation treatment for chronic pain

The Senza system [image from Nevro]Nevro (NYSE:NVRO) announced today that UnitedHealthcare will provide coverage for its painful diabetic neuropathy (PDN) treatment.

Redwood City, California-based Nevro’s Senza 10 kHz spinal cord stimulation (SCS) therapy will now be covered by the largest private health insurance company in the U.S. for dates of service on or after March 1, 2022, according to a news release.

Under the policy, UnitedHealthcare considers Nevro’s high-frequency SCS system to be proven and medically necessary for the treatment of diabetic neuropathy when specified criteria are met.

Senza received FDA approval for treating chronic pain associated with PDN in July 2021. The company said at the time that Senza is the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN.

“We believe this expeditious coverage decision from UnitedHealthcare following our submission to their medi…

How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre-pandemic years. The handful of companies that joined this yea…

How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]

Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre…

Nevro plummets before hours on mixed bag Q2 results

Nevro (NYSE:NVRO) today posted second-quarter results that beat the earnings consensus on Wall Street but missed revenue estimates.

The Redwood City, Calif.-based company reported losses of -$21.6 million, or -62¢ per share, on sales of $102.3 million for the three months ended June 30 for a sales growth of 81.47% compared with Q2 2020.

Earnings per share were -62¢, 11¢ ahead of The Street, where analysts were looking for sales of $102.7 million.

“The recovery of procedural volumes in the pain market generally and the SCS market specifically has been slower than we anticipated, impacting not only second-quarter revenues, but in the case of lower trial procedures, revenue in future months as well,” CEO and president Keith Grossman said in a news release. “In light of the lack of visibility around COVID-related recovery trends and timelines, the company is providing third quarter guidance only. While the slower COVID recovery environment …

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

The Senza system [image from Nevro]Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN.

Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN (painful diabetic neuropathy).

FDA approval follows the published results of the SENZA-PDN trial in JAMA Neurology, which demonstrated the safety and efficacy of the spinal cord stimulation (SCS) system.

In April, Nevro touted results from the randomized SENZA-PDN trial, which met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said. The trial pitted Senza, plus conventional medical …

9 medical devices you should keep an eye out for in 2021

The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021.

Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek approval or launch a wide range of new products.

Think surgical robotics, smart orthopedic implants, neurostimulation, single-use scopes and much more.

Here are nine devices to especially keep an eye out for this year.

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