Globus Medical Announces Launch of ELSA® Expandable Lateral Spacer System
April 05 2018 - 4:15PM
Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal
solutions company, today announced the launch of two innovative
lateral expandable interbody spacers with integrated screw
fixation, ELSA® AL and ELSA®-ATP, the latest additions to Globus’
unmatched expandable solutions. These next generation expandable
implants provide an optimized fit for the patient, allowing for
restoration of sagittal balance and enhanced structural fixation.
Globus Medical is the market leader in expandable interbody
spacers with over 20 expandable implant solutions supported by 15
years of clinical experience. Globus Medical’s full line of
expandable products has enabled surgeons to treat over 130,000
levels.
“ELSA® AL is the alternative to RISE®-L for selected cases in
which maximizing segmental lordosis is indicated,” said Dr. Paul K.
Kim, neurosurgeon at Carolina Neurosurgery & Spine Associates.
“In conjunction with the ALL (anterior longitudinal ligament)
release technique, ELSA® AL has the potential to provide the most
amount of segmental lordosis of any device on the market.”
Adjustable Lordosis Technology with ELSA®
AL
ELSA® AL’s in situ adjustability and integrated screw fixation
are designed to help correct sagittal balance and improve
stability. The implant features exclusive adjustable lordotic
technology that allows up to 30° of lordosis while maintaining a
minimally invasive surgical corridor. With less disruption compared
to traditional static spacers, ELSA® AL provides maximum correction
and additional fixation for increased segmental stability.
First Expandable Spacer for a Customized ATP
Approach
ELSA®-ATP is the only expandable spacer designed to avoid nerve
complications associated with the direct lateral technique by using
an anterior-to-psoas approach.
The Lateral Lumbar Interbody Fusion (LLIF) technique approaches
the spine from the side of the patient, which allows for placement
of a larger implant footprint and less disruption of the lower back
muscles. The anterior-to-psoas approach is a modified LLIF
procedure that avoids the psoas, a large muscle responsible for
movement and flexion of the leg. Avoiding this muscle and its
integrated nerves may help reduce post-operative complications such
as thigh pain.
ELSA®-ATP features angled integrated screws for direct fixation
to the adjacent vertebrae. The spacer can be inserted at a minimal
height and expanded in situ to minimize tissue disruption and
maximize indirect decompression. A full suite of anterolateral
access and insertion instruments makes ELSA®-ATP the most
comprehensive system on the market.
“Our product development team’s continued commitment to
innovation has enabled us to design expandable interbody technology
for nearly every surgical approach. The addition of these two
unique ELSA® spacers to our expandable lateral portfolio
demonstrates our commitment to listening and responding to our
customers’ needs through continuous product innovation,” said
Andrew Iott, Senior Vice President of Global Product Development.
“The use of an expandable spacer for the ATP approach may help
reduce complications associated with the lateral procedure.
With restoration of alignment being of critical importance, these
implants were developed as a tool to help surgeons address sagittal
imbalance, with the goal of maximizing lordotic correction.”
Learn more about ELSA® and Globus Medical’s full line of
expandable interbody spacers at
www.GlobusMedical.com/Expandables.
Indications
The ELSA® Spacer is an interbody fusion device intended for use
in patients with degenerative disc disease (DDD) at one or two
contiguous levels of the lumbosacral spine (L2-S1). DDD is defined
as discogenic back pain with degeneration of the disc confirmed by
history and radiographic studies. These patients should be
skeletally mature and have had at least six (6) months of
non-operative treatment. In addition, these patients may have up to
Grade 1 spondylolisthesis or retrolisthesis at the involved
level(s). The ELSA™ Spacer is to be filled with autograft and/or
allogenic bone graft comprised of cancellous and/ or
corticocancellous bone, may be used with two bone screws, and is to
be used with supplemental fixation. Hyperlordotic (≥20°) implants
must be used with the two bone screws and supplemental fixation in
addition to the bone screws.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions
company based in Audubon, PA. The company was founded in 2003 by an
experienced team of professionals with a shared vision to create
products that enable surgeons to promote healing in patients with
musculoskeletal disorders. Additional information can be accessed
at http://www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than
statements of historical fact are forward-looking statements and
may be identified by their use of words such as “believe,” “may,”
“might,” “could,” “will,” “aim,” “estimate,” “continue,”
“anticipate,” “intend,” “expect,” “plan” and other similar terms.
These forward-looking statements are based on our current
assumptions, expectations and estimates of future events and
trends. Forward-looking statements are only predictions and are
subject to many risks, uncertainties and other factors that may
affect our businesses and operations and could cause actual results
to differ materially from those predicted. These risks and
uncertainties include, but are not limited to, factors affecting
our quarterly results, our ability to manage our growth, our
ability to sustain our profitability, demand for our products, our
ability to compete successfully (including without limitation our
ability to convince surgeons to use our products and our ability to
attract and retain sales and other personnel), our ability to
rapidly develop and introduce new products, our ability to develop
and execute on successful business strategies, our ability to
comply with changing laws and regulations that are applicable to
our businesses, our ability to safeguard our intellectual property,
our success in defending legal proceedings brought against us,
trends in the medical device industry, general economic conditions,
and other risks. For a discussion of these and other risks,
uncertainties and other factors that could affect our results, you
should refer to the disclosure contained in our most recent annual
report on Form 10-K filed with the Securities and Exchange
Commission, including the sections labeled “Risk Factors” and
“Cautionary Note Concerning Forward-Looking Statements,” and in our
Forms 10-Q, Forms 8-K and other filings with the Securities and
Exchange Commission. These documents are available at www.sec.gov.
Moreover, we operate in an evolving environment. New risk factors
and uncertainties emerge from time to time and it is not possible
for us to predict all risk factors and uncertainties, nor can we
assess the impact of all factors on its business or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statements. Given these risks and uncertainties,
readers are cautioned not to place undue reliance on any
forward-looking statements. Forward-looking statements contained in
this press release speak only as of the date of this press release.
We undertake no obligation to update any forward-looking statements
as a result of new information, events or circumstances or other
factors arising or coming to our attention after the date
hereof.
Contact:Brian KearnsVice President, Business
Development and Investor RelationsPhone: (610) 930-1800Email:
investors@globusmedical.comwww.globusmedical.com
Globus Medical (NYSE:GMED)
Historical Stock Chart
From Mar 2024 to Apr 2024
Globus Medical (NYSE:GMED)
Historical Stock Chart
From Apr 2023 to Apr 2024