REDWOOD CITY, Calif. - Nevro Corp. (NYSE: NVRO), a global medical device company, has received U.S. Food and Drug Administration (FDA) clearance for its sacroiliac joint fusion device, Nevro1. The device, which has been cleared for use without the inclusion of Nevro's lateral screw, NevroFix™, utilizes integrated transfixing technology to stabilize the sacroiliac (SI) joint, allowing for potential long-term fusion.
The device's deployable titanium anchors are designed to enhance the axial and rotational stability of the joint. Nevro1 also features 3D-printed technology aimed at promoting bone cell growth to facilitate joint fusion. The clearance of Nevro1 follows Nevro's acquisition of Vyrsa™ Technologies in November 2023, expanding the company's offerings in minimally invasive treatment options for chronic SI joint pain.
Dr. Gregory Bailey, an orthopedic surgeon, has endorsed Nevro1 as a significant advancement in SI fusion, citing its safety and efficiency. Nevro's CEO, Kevin Thornal, stated that Nevro1 will serve as the company's flagship product in the SI joint fusion market, complementing their comprehensive portfolio of SI joint solutions.
This FDA clearance marks a new chapter for Nevro, which has previously developed its proprietary 10 kHz Therapy™, impacting over 100,000 patients worldwide. The company's HFX™ spinal cord stimulation platform, including the Senza® SCS system, provides support services for the treatment of chronic trunk, limb, and diabetic neuropathy pain.
Nevro's portfolio now covers a range of chronic pain treatments, including the latest SI joint fusion technology, designed to cater to different physician preferences and patient needs. The company continues to encourage investors and potential investors to consult its website for important information.
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