SANTA CLARA, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) — SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical machine firm devoted to fixing musculoskeletal problems of the sacropelvic anatomy, declares FDA 510(okay) premarket clearance of the iFuse Bedrock Granite® Implant System (Granite) in a smaller (9.5 mm) diameter with each an expanded indication in pediatric sufferers and an expanded utility that features use within the S1 trajectory. When positioned throughout the SI joint, the Granite implant gives sacroiliac fusion and sacropelvic fixation as a foundational aspect for multi-segment spinal fusion.
This 510(okay) clearance follows the preliminary clearance of the iFuse Bedrock Granite System in Could 2022 that included implants of 10.5 mm and 11.5 mm in diameter. The iFuse Bedrock Granite System was additionally awarded a Breakthrough Machine Designation (BDD) by the Food & Drug Administration (FDA) and a New Know-how Add-on Cost (NTAP) by the Facilities for Medicare and Medicaid Providers (CMS).
In line with Chris Shaffrey, MD, Chief of the Backbone Division at Duke College, “The addition of a 9.5 mm diameter implant will seamlessly mix into my workflow, particularly with each closed head and open head choices. I’m very excited for sufferers to profit from this breakthrough spinopelvic expertise.”
“With the expanded sacral indication and a smaller diameter Granite implant, I can make the most of the Granite expertise at S1, a phase which revealed literature has proven to be one of the vital difficult segments within the spine, with reported screw loosening charges starting from 16-41%,”1,2,3 stated Brian A. O’Shaughnessy, MD, Reconstructive Spinal Surgeon at Howell Allen Clinic in Nashville, TN.
Greg Mundis, MD, Orthopedic Backbone Surgeon at Scripps Hospital mentions, “There’s rising curiosity among the many surgeon group to incorporate pelvic fixation in high-risk sufferers present process shorter (2-3 stage) lumbar fusions. The addition of a 9.5 mm diameter to the Granite product line now provides surgeons one of many extra generally used sizes to deal with these sufferers.”
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a world chief in expertise for surgical therapy of musculoskeletal problems of the sacropelvic anatomy. Since pioneering minimally invasive surgical procedure of the SI joint in 2009, SI-BONE has supported over 3,600 surgeons in performing a complete of greater than 95,000 sacropelvic procedures. A singular physique of scientific proof helps the usage of SI-BONE’s applied sciences, together with two randomized managed trials and over 125 peer reviewed publications. SI-BONE has leveraged its management in minimally invasive SI joint fusion to commercialize novel options for adjoining markets, together with grownup deformity, spinopelvic fixation, and pelvic trauma.
For added info on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com.
iFuse Bedrock Granite, iFuse-TORQ and SI-BONE are registered emblems of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved.
Investor Contact: Saqib Iqbal traders@si-bone.com
References
- Xu F, Zhou S, Zou D, Li W, Solar Z, Jiang S. The connection between S1 screw loosening and postoperative end result in sufferers with degenerative lumbar scoliosis. BMC Musculoskelet Disord. 2022 Feb 28;23(1):186.
- Kim JB, Park SW, Lee YS, et al. The consequences of spinopelvic parameters and Paraspinal muscle degeneration on S1 screw loosening. J Korean Neurosurg Soc. 2015;58(4):357–362.
- Finger T, Bayerl S, Onken J, et al. Sacropelvic fixation versus fusion to the sacrum for spondylodesis in multilevel degenerative spine illness. Eur Backbone J. 2014;23(5):1013–1020.
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