Silicon Valley-based SI-BONE, Inc. has received additional FDA 510(k) clearance “for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures.”
The iFuse Implant System, available since 2009, had been cleared in November 2018 for sacroiliac fusion using a dorsal, or posterior, implantation approach to treat SI joint dysfunction in patients also undergoing long fusion procedures involving a posterior approach. “With this new broader indication, iFuse Bedrock can now be placed across the SI joint as an adjunct to long fusion procedures with the intent of gaining fusion to augment immobilization and stabilization of the SI joint,” stated an April 15, 2019 company announcement.
Company 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.”
iFuse Implant System
According to FDA documents, 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 system consists of cannulated triangular, titanium (iFuse implants:Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTMF3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint.”
“The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).”
The company stated that 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.”
