Nevro has gained U.S. Food and Drug Administration (FDA) clearance for its sacroiliac (SI) joint fusion devices, Nevro1, without needing to include the NevroFix screw.
 
Nevro1 is an integrated transfixing technology for the SI joint to allow opportunity for long-term fusion. It uses self-contained, deployable titanium anchors to transfix the sacrum and ilium to boost the joint’s axial and rotational stability.
 
The company said its instrumentation permits optimal intra-articular SI joint preparation, critical for joint fusion. Nevro1 features 3D-printed, bone-growth stimulating tech to promote bone cell browth.
 
This represents the first regulatory clearance since Nevro bought Vyrsa Technologies in November 2023. Vyrsa provided the company with minimally invasive treatment options for chronic SI joint pain. The company noted the clearance was originally received by Camber Spine and will be transferred to Nevro for marketing and distribution.
 
“Nevro1 will be our flagship SI joint fusion product as there is no other device like it on the market,” said Nevro president and CEO Kevin Thornal. “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.”