Data Showcasing Strength of RTI’s SImmetry® System in Sacroiliac Joint Fusion Published in The Spine Journal
March 28 2018 - 7:00AM
Business Wire
Study finds SImmetry significantly reduces
range of motion and provides an environment for fusion in the
sacroiliac (SI) joint, a central goal for treating long-term SI
joint dysfunction
RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant
company, today announced data on the SImmetry® Sacroiliac Joint
Fusion System have been published in The Spine Journal, the
official journal of the North American Spine Society. The study
results demonstrate the SImmetry System produces effective joint
fixation, markedly reducing range of motion (ROM) in the SI joint.
The SImmetry System is the only minimally-invasive surgical
procedure that uses proprietary decortication technology to help
facilitate bone fusion, providing opportunity for long-term
relief.
“These results reinforce the effectiveness of the SImmetry
System in aiding patients who suffer from chronic low back pain
caused by SI joint dysfunction,” said Camille Farhat, President and
CEO, RTI Surgical. “The SImmetry System is the only
minimally-invasive surgical procedure that promotes SI joint fusion
through decortication, reducing the range of motion in all
directions with only two implants.”
RTI Surgical recently acquired the SImmetry System as it
continues to invest in advanced spinal surgery innovations
supported by clinical data, including minimally-invasive
technologies that ease the surgical experience and may help patient
outcomes.
About The Study: “Biomechanical Evaluation of Sacroiliac
Joint Fixation with Decortication”
The manuscript describes the results of a human cadaveric
biomechanical study in which two minimally-invasive techniques for
placing primary (12.5mm) and secondary (8.5mm) threaded implants
were compared for their effectiveness in stabilizing the SI joint.
The study also evaluated the link between fixation and bone mineral
density, as well as the impact of removing the secondary implant on
construct rigidity. Fourteen human cadaveric SI joints were
prepared, grafted and then fixated using threaded SImmetry
implants. Mechanical testing on the rigidity of the construct and
ROM calculation was completed at the study initiation with the
joint intact, after destabilization, after implantation, and after
removal of the secondary implant.
This biomechanics study found that the SImmetry implants
provided a significant, 65-71 percent reduction in joint motion
using multiple configurations of the implants. This benefit was
maintained after repeated loading, and was greater than that seen
in previous studies using triangular SI joint implants. The
results provided evidence of immediate fixation, which is intended
to relieve pain and provide an environment suited to bone growth
across the joint, which is the ultimate goal in long-term relief of
SI joint pain.
Growing Body of Evidence on SImmetry System
These study results support the growing body of evidence on the
effectiveness of the SImmetry System. The ongoing EVoluSIon
Clinical Study is evaluating the impact of SImmetry on SI joint
fusion and pain reduction in up to 250 patients at up to 40 sites.
More than 180 patients have been enrolled to date. An early
analysis of the first 50 patients published in December 2017 showed
a 54 percent reduction in SI joint pain at six months as well as a
55 percent reduction in opioid use.1 A separate CT fusion study on
the SImmetry System demonstrated a 73 percent reduction in average
pain over 24 months.2 Additional data from the EVoluSIon Clinical
Study will be presented at the upcoming International Society for
the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting taking
place April 11-13 in Toronto, Canada.
Approximately 20 percent of all chronic low back pain derives
from the SI joint,3 which links the base of the spine to the pelvic
bone. When nonsurgical therapy is ineffective in managing SI joint
pain, surgical fusion is a viable long-term option. Traditional
open fixation is a complex and invasive procedure associated with
considerable morbidity and risk of injury.4
About RTI Surgical, Inc.
RTI Surgical is a leading global surgical implant company
providing surgeons with safe biologic, metal and synthetic
implants. Committed to delivering a higher standard, RTI’s implants
are used in sports medicine, general surgery, spine, orthopedic,
trauma and cardiothoracic procedures and are distributed in nearly
50 countries. RTI has four manufacturing facilities throughout the
U.S. and Europe. RTI is accredited in the U.S. by the American
Association of Tissue Banks and is a member of AdvaMed. For more
information, please visit www.rtix.com.
Forward-Looking Statements
This communication contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements are based on management’s
current expectations, estimates and projections about our industry,
our management's beliefs and certain assumptions made by our
management. Words such as "anticipates," "expects," "intends,"
"plans," "believes," "seeks," "estimates," variations of such words
and similar expressions are intended to identify such
forward-looking statements. In addition, except for historical
information, any statements made in this communication about
anticipated financial results, growth rates, new product
introductions, future operational improvements, gaining market
share and results or regulatory actions or approvals or changes to
agreements with distributors also are forward-looking statements.
These statements are not guarantees of future performance and are
subject to risks and uncertainties, including the risks described
in public filings with the U.S. Securities and Exchange Commission
(SEC). Our actual results may differ materially from the
anticipated results reflected in these forward-looking statements.
Copies of the company's SEC filings may be obtained by contacting
the company or the SEC or by visiting RTI's website at www.rtix.com
or the SEC's website at www.sec.gov.
1 Araghi A et al. Pain and Opioid use Outcomes Following
Minimally Invasive Sacroiliac Joint Fusion with Decortication and
Bone Grafting: The Evolusion Clinical Trial. Open Orthop J.
2017;11:1440-1448.2 Cross W et al. Minimally Invasive Sacroiliac
Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a
Principles-Based SIJ Fusion System. Open Orthop J. 2018 Jan
17;12:7-16.3 Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive
Review of Epidemiology, Diagnosis and Treatment. Expert Rev
Neurother. 2013; 13(1):99-116.4 Snyder LA et al. The technological
development of minimally invasive spine surgery. Biomed Res
Int. 2014:293582.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180328005136/en/
RTI Surgical, Inc.Media ContactsAnnie Claggett,
+1-312-995-2856aclaggett@rtix.comorMolly Poarch,
+1-224-287-2661mpoarch@rtix.comorInvestor ContactNathan
Elwell, +1-847-530-0249nelwell@lincolnchurchilladvisors.com
RTI Surgical (NASDAQ:RTIX)
Historical Stock Chart
From Mar 2024 to Apr 2024
RTI Surgical (NASDAQ:RTIX)
Historical Stock Chart
From Apr 2023 to Apr 2024