Full Press Release Details
SANTA CLARA, Calif., Sept. 05, 2023 (GLOBE NEWSWIRE) -- SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley-based medical device company focused on sacropelvic surgical solutions, today confirmed that certain 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 criteria for compatibility with iFuse Bedrock Granite® indicated in the Granite implant’s instructions for use. A complete list of Medtronic Solera® rods meeting the criteria for compatibility described in Granite’s cleared labeling is available on SI-BONE’s website at: http://www.si-bone.com/granite-implant-solera-compatbibility-criteria.
“Given the strong initial reception for Granite, we are thrilled to confirm that a number of Medtronic’s Solera® rods, used by many spine surgeons, meet Granite’s compatibility criteria,” said Laura Francis, CEO of SI-BONE. “Our existing general rod compatibility clearance, along with confirmation that these Medtronic Solera® rods meet the criteria for compatibility with the Granite implant will give spine surgeons additional confidence in using our leading pelvic fixation implant with the Medtronic Solera® system.”
The iFuse Bedrock Granite implant was cleared by FDA on May 26, 2022. FDA recognized the Granite implant’s significant advantages over existing approved or cleared alternatives in designating the product as a Breakthrough Device. CMS subsequently adopted a New Technology Add-on Payment of up to $9,828 per procedure, based on the individual hospital’s costs, for procedures reimbursed under the Medicare program and incorporating this new technology.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of musculoskeletal disorders of the sacropelvic anatomy. Since pioneering minimally invasive SI joint surgery in 2009, SI-BONE has supported over 3,000 surgeons in performing a total of over 80,000 sacropelvic procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and over 120 peer reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic fixation and pelvic trauma.
For additional information on the company or the products including risks and benefits, please visit www.si-bone.com. For the iFuse Bedrock Granite instructions for use, including indications for use and risk information, please visit www.si-bone.com/label.