Medical device-maker SI-BONE has secured the US Food and Drug Administration’s (FDA) additional 510(k) clearance for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures.
Image: SI-BONE wins FDA clearance for iFuse Bedrock technology. Photo: Courtesy of yodiyim/FreeDigitalPhotos.net.
iFuse Bedrock technology from SI-BONE, has been designed to provide greater stability of the joint at the base of long spinal constructs. Previously, FDA cleared iFuse sacroiliac fusion using a dorsal or posterior, implantation approach for treating SI joint dysfunction in patients also undergoing long fusion procedures with posterior approach.
With the new indication, iFuse Bedrock can be placed across the SI joint as an adjunct to long fusion procedures with the intention of gaining fusion to improve immobilization and stabilization of the SI joint.
The iFuse Implant System, which has been available since 2009, is used for sacroiliac fusion for conditions such as sacroiliac joint dysfunction that is the result of sacroiliac joint disruption and degenerative sacroiliitis. This covers the conditions whose symptoms start during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The system is also useful for sacroiliac fusion to increase immobilization and stabilizing the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of lumbar or thoracolumbar fusion.
It is claimed to be the only SI joint fusion device supported by multiple prospective clinical studies showing improved pain, patient function and quality of life from the treatment.
Adult spinal deformity surgery is seen as one of the fastest growing segments of the spine market with an estimated 50,000 procedures annually.
SI-BONE president, CEO and chairman Jeffrey Dunn said: “The iFuse technology provides spine surgeons with a novel spinopelvic fixation solution for their long construct cases.
“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.”