iFuse Bedrock is a technology designed to provide greater stabilization of the joint at the base of long spinal constructs. iFuse was previously cleared by the
“iFuse Bedrock potentially represents an important advancement in how we treat adult deformity patients,” said Dr.
Adult spinal deformity surgery represents one of the fastest growing segments of the spine market with an estimated 50,000 procedures per year. Pelvic stabilization of the sacroiliac joint is a well understood clinical need in spinal deformity patients who undergo long fusions to the sacrum.
“The iFuse technology provides spine surgeons with a novel spinopelvic fixation solution for their long construct cases,” said Jeffrey Dunn, President, Chief Executive Officer, and Chairman at SI-BONE. “As we enter the adult deformity market, we remain focused on our commitment to education and clinical evidence that has been the cornerstone of our company, as demonstrated by our 68 peer-reviewed publications including two randomized clinical trials and published long-term data out to six years involving use of iFuse to treat sacroiliac joint dysfunction.”
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit.
Joe PowersVice President of Marketing
Source: SI-BONE, Inc.