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Nevro Granted FDA 510(k) Clearance for SI Fixation System Excluding Lateral Screw Requirement

Thursday, February 29, 2024

Nevro Corp., a global leader in medical devices focused on improving chronic pain management, has announced FDA clearance for its sacroiliac joint fusion device, branded as Nevro1, eliminating the need for screws. Nevro1 features integrated transfixing technology designed to stabilize the SI joint and potentially facilitate long-term fusion.

It employs self-contained titanium anchors for enhanced axial and rotational stability, vital for joint integrity. Nevro's specialized instrumentation ensures optimal intra-articular SI joint preparation, a critical factor for successful fusion.

The device incorporates 3D-printed technology to stimulate bone cell growth and fusion. Nevro1 represents a significant advancement in SI fusion technology, renowned for its safety, efficiency, and efficacy. This milestone follows Nevro's acquisition of Vyrsa™ Technologies in November 2023, expanding its offerings for chronic SI joint pain treatment. Originally cleared by Camber Spine, the FDA clearance now shifts to Nevro for marketing and distribution.

Source: prnewswire.com

 

 

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