SANTA CLARA, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) — SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley-based medical system firm targeted on sacropelvic surgical options, in the present day confirmed that sure CD Horizon® Solera® 5.5mm and 6.0mm posterior spinal fixation rods manufactured by Medtronic Sofamor Danek USA Inc., a division of Medtronic plc, meet SI-BONE’s standards for compatibility with iFuse Bedrock Granite® indicated within the Granite implant’s directions to be used. An entire listing of Medtronic Solera® rods assembly the factors for compatibility described in Granite’s cleared labeling is obtainable on SI-BONE’s web site at: http://www.si-bone.com/granite-implant-solera-compatbibility-criteria.
“Given the sturdy preliminary reception for Granite, we’re thrilled to verify that various Medtronic’s Solera® rods, utilized by many spine surgeons, meet Granite’s compatibility standards,” stated Laura Francis, CEO of SI-BONE. “Our present basic rod compatibility clearance, together with affirmation that these Medtronic Solera® rods meet the factors for compatibility with the Granite implant will give spine surgeons further confidence in utilizing our main pelvic fixation implant with the Medtronic Solera® system.”
The iFuse Bedrock Granite implant was cleared by FDA on Could 26, 2022. FDA acknowledged the Granite implant’s vital benefits over present permitted or cleared alternate options in designating the product as a Breakthrough System. CMS subsequently adopted a New Expertise Add-on Cost of as much as $9,828 per process, primarily based on the person hospital’s prices, for procedures reimbursed beneath the Medicare program and incorporating this new know-how.
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a worldwide chief in know-how for surgical therapy of musculoskeletal issues of the sacropelvic anatomy. Since pioneering minimally invasive SI joint surgical procedure in 2009, SI-BONE has supported over 3,000 surgeons in performing a complete of over 80,000 sacropelvic procedures. A singular physique of medical proof helps using SI-BONE’s applied sciences, together with two randomized managed trials and over 120 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 data on the corporate or the merchandise together with dangers and advantages, please go to www.si-bone.com. For the iFuse Bedrock Granite directions to be used, together with indications to be used and threat data, please go to www.si-bone.com/label.
SI-BONE and iFuse Bedrock Granite are registered emblems of SI-BONE, Inc. Medtronic, CD Horizon and Solera are registered emblems of Medtronic, Inc. and are used herein with the consent of Medtronic. ©2023 SI-BONE, Inc. All Rights Reserved.
Sr. Director, FP&A and Investor Relations