SI-BONE, Inc. Announces iFuse Bedrock Granite® Implant System Compatibility with Certain Medtronic CD Horizon® Solera® 5.5/6.0 System Rods
05 Setembro 2023 - 5:09PM
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.
About SI-BONE, Inc.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.
SI-BONE and iFuse Bedrock Granite are registered trademarks of
SI-BONE, Inc. Medtronic, CD Horizon and Solera are registered
trademarks of Medtronic, Inc. and are used herein with the consent
of Medtronic. ©2023 SI-BONE, Inc. All Rights Reserved.
Investor Contact:
Saqib IqbalSr. Director, FP&A and Investor
Relationsinvestors@SI-BONE.com
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