Nevro Corp. a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain,announced the publication of new data in Medical Devices: Evidence and Research, which demonstrate the superiority of the Nevro1™ SI Joint Fusion System ("Nevro1").
A posterior integrated transfixation cage system offering enhanced stability, minimized bone removal and increased fusion potential compared to a posterolateral cylindrical threaded single-implant system. Nevro1's performance also showed that it is equivalent in osteopenic bone when compared to a lateral triangular rod system in healthy bone.
The sacroiliac (SI) joints constitute two out of five joints within the spine-pelvic-hip complex and are responsible for facilitating load transfer to the torso and lower extremities.1-3 Joint dysfunction can arise from conditions such as degeneration, instability, infection or adjacent segment disease, causing significant pain and impacting daily activities like walking, sitting and lifting.4-6 Women, in particular, may experience pronounced discomfort and reduced quality of life due to SI joint pain.7-8
The study concurrently assessed and compared the fixation efficacy, invasiveness and fusion potential of a posterior integrated transfixation cage system (Nevro1) to the posterolateral threaded implant and lateral triangular rod systems.
"The SI joint is a recognized contributor to low back pain, significantly affecting daily life for those impacted," said Douglas Beall, MD, FIPP, FSIR, Chief of Services, Comprehensive Specialty Care, Clinical Radiology of Oklahoma. "This study demonstrates the advantages of the posterior integrated cage system that spans the SI joint to stabilize it and to address pain associated with SI joint dysfunction. The Nevro1 device represents a significant advancement in SI joint fusion, offering greater fixation with increased fusion potential, and minimal bone removal compared to other options I have for my patients."
"These findings illustrate the potential benefits of the Nevro1 sacroiliac joint transfixing device, especially in terms of the post-surgical experience for the patient and opportunity for long-term fusion and improved patient outcomes," said David Caraway MD, PhD, Nevro's chief medical officer. "This latest study further establishes this technology as a promising treatment for patients suffering from SI joint pain."
About the Nevro1™ SI Joint Fusion System:
The Nevro1 System is an FDA 510k-cleared device intended to transfix the SI joint for immediate stability and long-term fusion. The mechanism of stabilization consists of integrated transfixing titanium anchors, which are deployed bilaterally and pierce through the cortices of the ilium and sacrum to provide immediate axial and rotational stability of the joint. This device has been proven to substantially reduce SI joint motion through comprehensive biomechanics testing performed in collaboration with the FDA. The proprietary implant design allows for a reduction in motion and abnormal stress on the SI joint without open surgery. Through a minimally invasive approach, the implant can be securely placed and may relieve pain and restore functionality to individuals suffering from chronic SI joint pain.
