SI-BONE Expands Portfolio with the Launch of New Offering for the iFuse Bedrock Granite Implant System and Completes Inaugural Surgical Procedures
07 5월 2024 - 10:00PM
SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical
device company dedicated to solving musculoskeletal disorders of
the sacropelvic anatomy, announced the first cases completed with
the smaller, 9.5 mm diameter, iFuse Bedrock Granite® Implant
(Granite 9.5). When placed across the SI joint, the Granite implant
provides sacroiliac fusion and spinopelvic fixation as a
foundational element for multi-segment spinal fusion.
This milestone for Granite 9.5 comes after
510(k) clearance in January 2024. The iFuse Bedrock Granite Implant
System was awarded a Breakthrough Device Designation by the Food
& Drug Administration and a New Technology Add-on Payment by
the Centers for Medicare and Medicaid Services. Granite 9.5 may be
more suitable for patients with smaller anatomy and may allow
easier placement of stacked implants in the sacroalar-iliac
trajectory. Moreover, the recent FDA clearance also includes use in
the S1 body of the sacrum and pediatric deformity.
“The technology delivered in the Granite
implants is improving traditional iliac fixation. More importantly,
even with complex reconstructions, as in my experience for my first
Granite 9.5 case, the implant did not change my surgical workflow.
An implant that has the potential for improved patient outcomes
through enhanced fixation without requiring a change in workflow
will be extremely beneficial to surgeons and our patients,” said
Ronald Lehman, Jr., MD, an orthopedic surgeon at New York
Presbyterian Allen / Och Spine Hospital at Columbia University (New
York, NY). Dr. Lehman is not a paid Consultant for SI-BONE,
Inc.
C.J. Kleck, MD, an orthopedic surgeon at the
University of Colorado (Denver, CO) said, “The new Granite 9.5 will
enable me to fit dual sacroalar-iliac Granite implants more easily
into the pelvis at the base of my spine fusions. This four-implant
Granite construct reduces range of motion at the SI joints and
L5-S1 segment, while reducing stress on the S1 pedicles screws1.
This provides a stable foundation for my spine fusion
patients.”
“Granite 9.5 provided outstanding tactile
feedback upon insertion, equivalent to what I’ve experienced using
the 10.5 mm Granite implants”, Ali Mesiwala, MD, FAANS, a
neurosurgeon at the Los Angeles-based DISC Sports & Spine
Center, stated. “This new diameter gives the Granite system even
greater optionality to help me utilize this breakthrough technology
in treating more of my patients.”
According to Victor Chang, MD, a neurosurgeon at
Henry Ford Health in West Bloomfield, MI, “The addition of Granite
9.5 and shorter lengths worked seamlessly in helping me revise
failed S1 screws. The S1 Granite 9.5 implants were a welcome
addition to the 10.5 mm Granite implants I use for sacroalar-iliac
fixation in my constructs. I’m very excited to have the additional
sizes available as it will allow more opportunities to incorporate
robust fixation with Granite into my cases.”
“Granite has been a resounding success for us
since the product was launched in 2022. It allowed us to target an
exciting billion-dollar market by addressing a significant unmet
clinical need at the foundation of multi-segment spinal fusion
procedures,” said Laura Francis, Chief Executive Officer. “Given
the surgeon enthusiasm around the smaller diameter implant, we are
poised to accelerate the adoption of Granite across the nearly
130,000 annual adult deformity and degenerative spine target
procedures.”
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
surgery of the SI joint in 2009, SI-BONE has supported over 3,700
surgeons in performing a total of more than 100,000 sacropelvic
procedures. A unique body of clinical evidence supports the use of
SI-BONE’s technologies, including two randomized controlled trials
and over 135 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.
iFuse Bedrock Granite and SI-BONE are registered
trademarks of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights
Reserved.
Investor Contact: Saqib Iqbal
investors@si-bone.com
1 Panico, M., et al. Stability and
Instrumentation Stresses Among Sacropelvic Fixation Techniques With
Novel Porous Fusion/Fixation Implants: A Finite Element Study
International Journal of Spine Surgery (July 2023)
SI BONE (NASDAQ:SIBN)
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부터 11월(11) 2024 으로 12월(12) 2024
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