New EVoluSIon Study Data Demonstrates Strong Support for the SImmetry® Sacroiliac Joint Fusion System
March 24 2022 - 9:00AM
Surgalign Holdings, Inc. (NASDAQ: SRGA), a global medical
technology company focused on elevating the standard of care by
driving the evolution of digital health, today announced the
publication of results from EVoluSIon (EVSI), a large, prospective,
multi-center study of clinical outcomes following minimally
invasive sacroiliac joint (SIJ) fusion with decortication.
Published in the February 2022 issue of the
International Journal of Spine Surgery, Clinical Outcomes Following
Minimally Invasive Sacroiliac Joint Fusion with Decortication: The
EVoluSIon Clinical Study1, reports 12-month clinical outcomes
following minimally invasive SIJ fusion using the SImmetry
Sacroiliac Joint Fusion system to treat SIJ dysfunction. With 250
patients and 23 sites participating, EVSI is one of the largest SIJ
fusion studies conducted to date.
The 12-month results from EVSI demonstrated
statistically significant improvements in both pain and disability,
along with a statistically significant reduction in the number of
patients using opioids.
More specifically, 72.2% of patients achieved the
minimal clinically important difference (MCID) criteria of
reduction in VAS, a measure of pain; 62.5% of patients achieved the
MCID criteria of reduction in ODI, a measure of disability; 57.1%
of patients reported (N=201) cessation of opioid use; and 68.7%
achieved radiographic fusion. These results compare favorably to
published competitive data2,3,4,5 and are consistent with prior
SImmetry publications6,7. Surgalign is only the second company to
report data on a study of this scale to offer a procedural solution
with statistically significant data for SIJ fusion.
“The EVSI study results provide significant
empirical support for both minimally-invasive SIJ fusion as well as
the SImmetry SIJ Fusion System with its unique decortication and
bone grafting instrumentation,” stated lead investigator Donald
Kucharzyk, DO. “Not only did EVSI demonstrate pain relief, improved
functionality, and reduction in opioid usage, it showed us that our
technique is broadly reproducible and results in intra-articular
fusion.”
Added Dr. Kucharzyk, “The most gratifying aspect of
this procedure is the patients’ satisfaction and how happy and
pleased they are with the results. SImmetry truly gives us a
solution to a complex problem that for a long time has been
overlooked.”
“We are excited about the publication of the
EVoluSIon study, as it demonstrates improved patient outcomes due
to our unique approach to SIJ fusion,” said Doug Bireley, executive
vice president of marketing and business development at Surgalign.
“We believe the SIJ fusion market provides a large opportunity for
Surgalign to provide excellent care and long-term relief for
patients with SIJ dysfunction.”
About SImmetry
The SImmetry system was designed from the outset to
not just fixate, but to also fuse the SI joint. The SImmetry system
is a minimally invasive SI joint fusion system that uses proven
orthopedic principles, including joint decortication, bone grafting
and fixation, to achieve true arthrodesis. The ultimate goal of SI
joint fusion is to stabilize the sacroiliac joint to relieve pain
due to joint disruption and degeneration.
About SIJ Dysfunction
The SIJ has been reported to be the source of pain
in approximately 18-30% of patients presenting with chronic low
back pain8,9,10, and increases to more than 40% in patients with
prior lumbar fusion11,12. SIJ dysfunction often occurs in
combination with other pathologies and must be carefully diagnosed.
Both NASS (North American Spine Society) and ISASS (International
Society for the Advancement of Spine Surgery) have published
diagnostic algorithms to aid in accurate SIJ diagnosis.
About Surgalign Holdings, Inc.
Surgalign Holdings, Inc. is a global medical
technology company committed to the promise of digital health to
drive transformation across the surgical landscape. Uniquely
aligned and resourced to advance the standard of care, the company
is building technologies physicians and other health providers will
look to for what is truly possible for their patients. Surgalign is
focused on developing solutions that predictably deliver superior
clinical and economic outcomes. Surgalign markets products
throughout the United States and in more than 50 countries
worldwide through an expanding network of top independent
distributors. Surgalign is headquartered in Deerfield, IL, with
commercial, innovation and design centers in San Diego, CA, Warsaw
and Poznan, Poland, and Wurmlingen, Germany. Learn more at
www.surgalign.com and connect on LinkedIn and Twitter.
- Kucharzyk D, Colle
K, Boone C, Araghi A. Clinical Outcomes Following Minimally
Invasive Sacroiliac Joint Fusion With Decortication: The EVoluSIon
Study. Int J Spine Sur 2022, 16 (1) 168-175.
doi: https://doi.org/10.14444/8185.
- Duhon BS, et al.
Triangular Titanium Implants for Minimally Invasive Sacroiliac
Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter
Trial. Int J Spine Surg. 2016;10:Article 13.
- Polly DW, et al.
Two-Year Outcomes from a Randomized Controlled Trial of Minimally
Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for
Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016;10: Article
28.
- Dengler J, et al.
Randomized Trial of Sacroiliac Joint Arthrodesis Compared with
Conservative Management for Chronic Low Back Pain Attributed to the
Sacroiliac Joint. J Bone Joint Surg Am. 2019;101(5):400-411.
- Patel v, et al.
Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed
Triangular Titanium Implants: 24-Month Follow-Up. Med Devices
(Auckl). 2020;14:211-216.
- Cross WW, et al.
Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and
Clinical Outcomes with a Principles-Based SIJ Fusion System. Open
Orthop J. 2018; 12: 7–16.
- Abbasi H, Hipp JA.
The Assessment of Fusion Following Sacroiliac Joint Fusion Surgery.
Cureus 9(10): e1787.
- DePalma MJ, et al.
What is the source of chronic low back pain and does age play a
role? Pain Med. 2011;12(2):224‐233.
- Schwarzer AC, et
al. The sacroiliac joint in chronic low back pain. Spine
(Phila Pa 1976). 1995; 20(1):31‐37.
- Bernard TN Jr,
Kirkaldy-Willis WH. Recognizing specific characteristics of
nonspecific low back pain. Clin Orthop Relat Res.
1987;(217):266‐280.
- DePalma MJ, et al.
Etiology of chronic low back pain in patients having undergone
lumbar fusion. Pain Med. 2011;12(5):732‐739.
- Maigne JY, Planchon
CA. Sacroiliac joint pain after lumbar fusion. A study with
anesthetic blocks. Eur Spine J. 2005;14(7):654‐658.
Investor and Media Contact: Mike
Vallie IR@surgalign.com +1 443 213 0499 |
Surgalign Contact:Kristine
Simmonsksimmons@surgalign.com+1 619 206 4648 |
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