Nevro enrolls first patient in PDN Sensory study

Nevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study.

The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S.

Patients in the trial will be randomized to conventional medical management or 10 kHz Therapy, along with conventional medical management with optional crossover to the other treatment arm at 6 months if the criteria are met.

The FDA previously granted breakthrough device designation for the study and the potential device indication. The FDA’s designation enables Nevro to receive a quicker review for its marketing application, which seeks to broaden its FDA labeling. This will give patients and healthcare providers faster access to vital medical devices that can provide improved treatment or diagnosis of serious, irrever…

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Nevro fully launches HFX iQ spinal cord stimulation

The HFX iQ SCS system. [Image courtesy of Nevro]Nevro (NYSE:NVRO) announced today that it initiated the full U.S. market launch for its HFX iQ spinal cord stimulation (SCS) system.

Redwood City, California-based Nevro designed HFX iQ for treating chronic pain. The company commenced its full launch after it completed a successful limited market release.

In a news release, Dr. Usman Latif called HFX iQ “the future of medicine.” Latif is an interventional pain specialist at the University of Kansas Medical Center. He added that the platform’s “expanded data holds the promise of new capabilities and improved care.”

About the Nevro HFX iQ system

HFX iQ utilizes the HFX algorithm to select programs most likely to provide pain relief for patients. Nevro built this on more than 20 million data points and 80,000 implanted patients. The system combines clinical inputs like pain relief and pain score to provide an individualized program s…

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Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

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Nevro announces CEO succession plan, preliminary Q4 results

[Image from LinkedIn]Nevro (NYSE:NVRO) today announced that Chair, CEO and President D. Keith Grossman intends to retire this year.

Grossman informed the board that he plans to retire from his CEO and president duties in 2023. He intends to do so following the selection of his successor at the spinal cord stimulation (SCS) technology developer.

Following the CEO succession, Grossman plans to continue to serve as chair of Nevro’s board. The board commenced a targeted search process for a new CEO with assistance from a leading executive search firm.

Grossman spent nearly 40 years as an executive in the medical device industry.

“I’m extremely proud of the significant progress we have made over the past four years, and I believe now more than ever Nevro is well-positioned for future growth and poised to enter an exciting period of progress,” Grossman said. “With what we believe will be continued recovery in our markets, important new products like …

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The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4% 

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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