Wednesday, May 08, 2024
SI-BONE, a medical device company headquartered in Silicon Valley, has announced successful initial cases using the smaller 9.5 mm diameter iFuse Bedrock Granite® Implant (Granite 9.5).
This implant, positioned across the SI joint, facilitates sacroiliac fusion and spinopelvic fixation, serving as a foundational component for multi-segment spinal fusion procedures.
The Granite 9.5 received 510(k) clearance in January 2024. Notably, it received Breakthrough Device Designation from the FDA and New Technology Add-on Payment from CMS.
The implant is particularly suited for patients with smaller anatomy and may streamline the placement of stacked implants in the sacroalar-iliac trajectory. Furthermore, its recent FDA clearance extends its use to the S1 body of the sacrum and pediatric deformity cases.
Surgeons have expressed optimism about the potential of Granite 9.5 to enhance patient outcomes without disrupting surgical workflows. orthopedic surgeon at New York Presbyterian Allen / Och Spine Hospital at Columbia University, highlighted the implant's ability to maintain surgical efficiency even in complex cases.
University of Colorado emphasized the ease of incorporating dual sacroalar-iliac Granite implants into spine fusions, leading to reduced motion at SI joints and the L5-S1 segment, thereby enhancing stability.
Praised the tactile feedback provided by Granite 9.5 during insertion, comparable to larger diameter implants, thereby expanding treatment options for patients.
Chang of Henry Ford Health in West Bloomfield, MI, found Granite 9.5 instrumental in revising failed S1 screws, enhancing robust fixation options in spinal constructs.
The positive reception of Granite since its launch in 2022 and highlighted the potential for accelerated adoption, particularly with the smaller diameter implant, catering to the significant demand in adult deformity and degenerative spine procedures.
Source: globenewswire.com
