Nevro (NYSE:NVRO) announced today that the FDA cleared its sacroiliac (SI) joint fusion device without the need to include an accompanying screw.
Redwood City, California-based Nevro plans to market this device as Nevro1, without the need for the NevroFix screw. The system aims to immediately transfix the SI joint, allowing the opportunity for long-term fusion. Self-contained, deployable titanium anchors transfix the sacrum and ilium to enhance the axial and rotational stability of the joint.
Additionally, Nevro’s system features proprietary instrumentation that allows for optimal intra-articular SI joint preparation. The company says this is a critical element in achieving joint fusion. Nevro1 also features 3D-printed bone-growth-enhancing technology, which helps promote bone cell growth and fusion as a result.
This marks the first regulatory clearance since Nevro acquired Vyrsa Technologies and its SI joint pain technologies last year. The FDA technically granted clearance to Camber Spine. That 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 Kevin Thornal, Nevro 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.”