SI-Bone has announced additional US Food and Drug Administration (FDA) clearance for its iFuse Bedrock Granite, including new indications with a wide variety of commercially available pedicle screw system rods.
The implant is typically used both to immobilise and fuse the sacroiliac (SI) joint and to serve as foundational support at the base of a spine fusion construct. The initial clearance included an indication for use with a single manufacturer’s pedicle screw system.
The expanded indications include use with a wide range of rods that are commonly used in multilevel spine fusion surgeries. The expanded indications will allow surgeons to use their preferred techniques and implant systems with confidence in conjunction with iFuse Bedrock Granite as the foundation for their construct, say SI-Bone.
Robert Eastlack, an orthopaedic surgeon at Scripps Hospital (San Diego, USA), said: “Many patients with spinal deformity require a thorough surgical plan and a variety of implant solutions to help provide the best outcome. By using iFuse Bedrock Granite at the base of my spinal constructs, I am providing my patients with the most advanced technology available.”
Laura Francis, CEO of SI-Bone, added: “Since launch, Granite has become the preferred implant for surgeons as they incorporate SI joint fusion into their pelvic fixation constructs. We believe that this expanded clearance will help increase the number of surgeons who treat their patients with this breakthrough device.”