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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.
Posted In: NVRO
