Nevro recently announced its Nevro1 SI Joint Fusion System has been shown to outperform traditional surgical approaches in stabilizing the sacroiliac (SI) joint and promote long-term fusion.
The research, published in Medical Devices: Evidence and Research, highlights Nevro1’s ability to reduce motion, enhance fusion potential, and minimize invasiveness, making it a groundbreaking option for patients with SI joint dysfunction.
“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 Dr. David Caraway, Nevro’s chief medical officer. “This latest study further establishes this technology as a promising treatment for patients suffering from SI joint pain.”
Study highlights Nevro1’s fixation and fusion capabilities
The research compared Nevro1 to two widely used alternatives, posterolateral cylindrical threaded implants and lateral triangular rod systems. It evaluated the systems on fixation efficacy, invasiveness and fusion potential, focusing on their ability to address SI joint pain, a leading cause of chronic lower back pain.
Key findings include:
- Motion reduction: Nevro1 and lateral triangular rods achieved equivalent reductions in motion across all planes, outperforming the posterolateral threaded implants in flexion-extension motion reduction.
- Fusion potential: Nevro1 provided the largest surface area for fusion among tested systems, improving the likelihood of robust SI joint arthrodesis.
- Minimally invasive approach: Nevro1 achieved superior outcomes with less bone removal and disruption than other systems, preserving the surrounding anatomy.
“The SI joint is a recognized contributor to low back pain, significantly affecting daily life for those impacted,” said Dr. Douglas Beall, 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.”
Designed for complex clinical needs
Nevro designed the Nevro1 system with transfixing titanium anchors that pierce through the cortices of the ilium and sacrum. This design provides immediate axial and rotational stability while creating optimal conditions for long-term fusion. Nevro1’s minimally invasive approach allows for precise implant placement without the need for open surgery.
According to the company, comprehensive biomechanic testing showed that the device significantly reduced SI joint motion and abnormal stress. As a result, patients had a reduced risk of complications, improved pain relief and restored functionality.
SI joint dysfunction is a prevalent cause of chronic pain, affecting millions of people worldwide. These joints are essential for transferring load between the spine, pelvis and lower extremities, and dysfunction can result in severe pain and mobility challenges. Conditions such as degeneration, instability and adjacent segment disease are common contributors.
Women are particularly vulnerable to SI joint-related pain, often experiencing pronounced discomfort that interferes with everyday activities like walking, sitting and lifting. Treatment options vary in effectiveness, making developing solutions like Nevro1 critical for improving patient care.