Nevro Receives FDA 510(k) Clearance to Use SI Fixation System Without Need to Include Lateral Screw

Rhea-AI Summary

Nevro Corp. announces FDA clearance for Nevro1, a sacroiliac joint fusion device without screws, featuring transfixing technology for long-term fusion. The device includes titanium anchors for stability and 3D-printed bone-growth technology. Positive feedback from orthopedic surgeons and CEO Kevin Thornal highlights its significance in the market.

Medical Device Analyst

The FDA clearance of Nevro1, a sacroiliac joint fusion device, is a significant milestone for Nevro Corp. This development could potentially disrupt the market for SI joint fusion solutions. The device's unique feature of not requiring a screw, dubbed 'NevroFix™,' simplifies the surgical procedure and reduces the risk of complications associated with additional hardware. The integration of 3D-printed, bone-growth enhancing technology within Nevro1 is particularly noteworthy, as it aligns with the growing trend towards personalized medicine and could lead to improved patient outcomes.

From an investment perspective, the clearance positions Nevro to capture a larger share of the orthopedic device market, which is highly competitive. The company's ability to offer a comprehensive portfolio in the SI joint space could attract a broader customer base, including both patients and physicians. The strategic acquisition of Vyrsa™ Technologies and the subsequent FDA clearance indicate Nevro's commitment to expanding its product offerings and enhancing its competitive edge.

Healthcare Market Analyst

The introduction of Nevro1 into the market could have ripple effects across the healthcare sector, particularly in the chronic pain management segment. Nevro's claim of Nevro1 being the safest and most efficient implant available, if substantiated by post-market data, could lead to increased adoption rates by healthcare providers. This would not only impact Nevro's revenue streams but also potentially reduce overall healthcare costs associated with chronic SI joint pain by providing a more effective long-term solution.

Moreover, the timing of the product's release, following the acquisition of Vyrsa™ Technologies, suggests a strategic move to leverage synergies and to capitalize on existing distribution channels. This could translate into accelerated market penetration and a strengthened position in the SI joint pain management market. Investors should monitor Nevro's market performance post-launch to gauge the actual impact on the company's financial health and market share.

Orthopedic Surgeon

From a clinical perspective, the Nevro1 device represents an innovative approach to SI joint fusion surgery. The immediate transfixion of the SI joint is a critical feature that may reduce the time needed to achieve fusion and enhance patient recovery. The device's design, which utilizes self-contained, deployable titanium anchors, could offer a more stable and durable solution compared to traditional fusion methods. The proprietary instrumentation for intra-articular joint preparation could also lead to more consistent surgical outcomes.

However, as with any new medical device, long-term clinical data will be essential to validate the safety and efficacy claims made by the manufacturer. Such data will be instrumental in determining whether Nevro1 becomes the standard of care for SI joint fusion procedures. The orthopedic community will be closely watching for peer-reviewed studies and patient follow-up results to assess the device's impact on the landscape of chronic pain treatment.

Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion

REDWOOD CITY, Calif., Feb. 28, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that the U.S. Food and Drug Administration (FDA) cleared its sacroiliac joint fusion device, which will be marketed as Nevro1, without the need to include the screw ("NevroFix™").

Nevro1, an integrated transfixing technology, is proven to immediately transfix the SI joint to allow the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance axial and rotational stability of the joint. In addition, Nevro's proprietary instrumentation allows for optimal intra-articular SI joint preparation which is critical to achieve joint fusion. Nevro1 comes with 3D-printed, bone-growth enhancing technology which helps promote bone cell growth and, as a result, fusion.

"Nevro1 as a standalone device represents the most significant advancement in SI fusion in years. In my experience, it is the safest and most efficient and effective true fusion implant available," said Gregory Bailey, M.D., an orthopedic surgeon in State College, Pennsylvania.

"Nevro1 will be our flagship SI joint fusion product as there is no other device like it on the market," said Kevin Thornal, Nevro's CEO and president. "We now offer one of the most comprehensive portfolios of products in the SI joint space, and we can meet the preferences of different physicians and varying patient needs – ultimately helping to improve health outcomes and quality of life for patients."

This is the first regulatory clearance since Nevro acquired Vyrsa™ Technologies, with its suite of innovative products that provide minimally invasive treatment options for patients suffering from chronic SI joint pain, in November 2023. The company noted that the clearance was originally received by Camber Spine and will be transferred to Nevro for marketing and distribution.

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

About Nevro

Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy™, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

Nevro recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Senza^®, Senza II^®, Senza Omnia^®, and HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy™. Nevro's unique support services provide every patient with HFX Coach™ support throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.

Senza, Senza II, Senza Omnia , Omnia,  10 kHz Therapy, HFX, HFX iQ, HFX Coach, HFX Cloud, NevroFix, NevroPro, Nevro1, Nevro, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents.

To learn more about Nevro, connect with us on LinkedIn, X, Facebook, and Instagram.

Investors and Media:

Angie McCabe
Vice President, Investor Relations & Corporate Communications
angeline.mccabe@nevro.com

 

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SOURCE Nevro Corp.

What is the name of the sacroiliac joint fusion device recently cleared by the FDA by Nevro Corp.?

The sacroiliac joint fusion device recently cleared by the FDA is named Nevro1.

What is the unique feature of Nevro1 that allows for long-term fusion of the SI joint?

Nevro1 features integrated transfixing technology that immediately transfixes the SI joint to allow for long-term fusion.

What technology does Nevro1 use to enhance stability of the SI joint?

Nevro1 uses self-contained, deployable titanium anchors to enhance axial and rotational stability of the SI joint.

What type of technology does Nevro1 have for promoting bone cell growth and fusion?

Nevro1 includes 3D-printed bone-growth enhancing technology to promote bone cell growth and fusion.

When was the first regulatory clearance received by Nevro after acquiring Vyrsa Technologies?

The first regulatory clearance received by Nevro after acquiring Vyrsa Technologies was in November 2023.

What did orthopedic surgeon Gregory Bailey say about Nevro1?

Orthopedic surgeon Gregory Bailey stated that Nevro1 is the safest, most efficient, and effective true fusion implant available.

Who mentioned that Nevro1 will be the flagship SI joint fusion product?

Nevro's CEO and president, Kevin Thornal, mentioned that Nevro1 will be the flagship SI joint fusion product.

What did Nevro acquire in November 2023 that led to the development of Nevro1?

Nevro acquired Vyrsa Technologies in November 2023, which contributed to the development of Nevro1.