ATEC Announces Commercial Release of Distinct, Comprehensive TLIF Approach
06 Octobre 2020 - 10:30PM
Alphatec Holdings, Inc. (“ATEC” or the “Company”) (Nasdaq:
ATEC), a medical device company dedicated to revolutionizing the
approach to spine surgery, announced today the commercial releases
of two new solutions designed to elevate the ATEC transforaminal
lumbar interbody fusion (TLIF) clinical experience. The Sigma
Access System and the InVictus Modular Pedicle Screw are novel
technologies that fully integrate with the SafeOp Neural InformatiX
system, the SingleStep implant delivery system and IdentiTi TLIF
implants, to enable a comprehensive, intelligently designed TLIF
approach.
“These new product releases further our
commitment to architect complete surgical procedures, the core
competency of the ATEC Organic Innovation Machine,” said Pat Miles,
Chairman and Chief Executive Officer. “The Sigma TLIF Access System
and InVictus Modular Screw solutions are not makeovers of existing
products. These technologies have been crafted from the ground up
to better meet the specific needs of the TLIF approach and effect a
more predictable, less disruptive technique. These products are
just two examples of the approach-based innovation that we are
releasing in 2020. ATEC continues to move spine surgery forward,
compelling surgeon adoption with distinct innovation that enhances
intraoperative confidence and improves surgical outcomes.”
Developed to address the unique requirements of
the TLIF technique, the Sigma TLIF Access System is ATEC’s first
pedicle-based access system, elegantly engineered to provide direct
visualization of key anatomical landmarks and improve the
reproducibility of the MIS TLIF approach. The Sigma TLIF
Retractor incorporates a fiber optic light source to improve
illumination and an integrated steerable jamshidi for unprecedented
shank navigability.
Samuel A. Joseph, Jr., MD, orthopedic spine
surgeon and founder of the Joseph Spine Institute in Tampa Bay,
Florida, commented, “The Sigma TLIF Retractor’s intuitive
features offer unique versatility. Independent cranial/caudal
opening or optional disc space distraction for collapsed disc
spaces were astutely built into the access system. I can
address unilateral pathology, or, if needed in complex cases,
address bi-lateral symptoms through simultaneous bi-lateral
approaches.”
Engineered to enhance the adaptability of the
InVictus spinal fixation platform with the power of modularity, the
InVictus Modular Pedicle Shank attaches directly to the Sigma TLIF
Access System. InVictus Modular incorporates visual, tactile, and
audible confirmation of tulip attachment to instill intraoperative
confidence. Integrated seamlessly with Single Step technology,
InVictus Modular extends the dependability and predictability of
InVictus MIS fixation and can obviate the need for guide wires,
which are commonly associated with surgical complications.
Dr. Andrew Roeser, MD, a Neurosurgeon at Houston
Methodist Hospital in Texas, added, “The seamless integration of
InVictus SingleStep & MIS MOD to the Sigma TLIF system make for
a highly efficient and reproducible procedure. By anchoring
the retractor blades to the spine, I am able to visualize the same
exposure every time, regardless of patient size. That is paramount
to consistent clinical outcomes, and incredibly helpful when
teaching residents in my O.R. Although there is soft tissue
covering the anatomy, each time I open the retractor, I can see the
headless screws and know exactly the location of pertinent
anatomy.”
The Sigma TLIF Access System and InVictus
Modular Fixation System will be highlighted this week at ATEC’s
virtual North American Spine Society, or NASS, booth. Click here,
or visit booth 1525 for more information.
Key Features of the
Sigma TLIF Access
System
-
Facilitates access to collapsed disc space through vertebral body
distraction
-
Improves illumination with integrated fiber optic light source
-
Provides direct visualization of facet, pars, and lamina with
modular shank and blade
-
Enables customized exposure with independent cranial and caudal
retraction
-
Supports differing patient pathology with surgeon-guided medial
blade
-
Streamlines assembly with quick-connect engagement
Key Features of the
InVictus Modular Fixation
Device
-
Leverages dependable helical flange tulip technology to reduce
cross-thread potential and help eliminate tulip splay
-
Boasts modular tulip interconnection strength 4.5x greater
than the average pull-out strength of pedicle screws
-
Adapts intraoperatively to surgical techniques with robust
instruments and customizable modular implants designed to
accept multiple rod diameters and materials
-
Advances the standard of Modular Fixation with a guidewire-less
SingleStepTM technique to deliver modular shank and SIGMA
blade with one instrument pass
-
Integrates with ATEC’s neural informatix system, SafeOp, to
predictability provide surgeons with real-time, actionable
information to detect and monitor the health of nerves at risk
during posterior fixation
-
Instills confidence with audible, tactile and visual confirmation
of reproducible Tulip to Shank attachment
About Alphatec
Holdings, Inc.
Alphatec Holdings, Inc. (ATEC), through its
wholly-owned subsidiaries, Alphatec Spine,
Inc. and SafeOp Surgical, Inc., is a medical device
company dedicated to revolutionizing the approach to spine surgery
through clinical distinction. ATEC’s Organic Innovation Machine is
focused on developing new approaches that integrate seamlessly with
the SafeOp Neural InformatiX System to safely and reproducibly
treat spine’s various pathologies and achieve the goals of spine
surgery. Alphatec’s vision is to become the Standard Bearer in
Spine. For more information, visit us
at www.atecspine.com.
Forward Looking
Statements This press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 that involve risks
and uncertainty. Such statements are based on management's current
expectations and are subject to a number of risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. The Company cautions
investors that there can be no assurance that actual results will
not differ materially from those projected or suggested in such
forward-looking statements as a result of various factors.
Forward-looking statements include references to the Company’s
planned commercial launches, product introductions and product
integration, surgeon and market acceptance of Company products,
solutions and platforms, and the Company’s ability to deliver key
product features. The important factors that could cause
actual operating results to differ significantly from those
expressed or implied by such forward-looking statements include,
but are not limited to: the uncertainty of success in developing
new products or products currently in the Company’s pipeline;
failure to achieve acceptance of the Company’s products by the
surgeon community; failure to obtain FDA or other
regulatory clearance or approval for new products, or unexpected or
prolonged delays in the process; continuation of favorable third
party reimbursement for procedures performed using the Company’s
products; the Company’s ability to compete with other products and
with emerging new technologies; product liability exposure; patent
infringement claims; and claims related to the Company’s
intellectual property. The words “believe,” “will,” “should,”
“expect,” “intend,” “estimate,” “look forward” and “anticipate,”
variations of such words and similar expressions identify
forward-looking statements, but their absence does not mean that a
statement is not a forward-looking statement. A further list
and description of these and other factors, risks and uncertainties
can be found in the Company's most recent annual report, and any
subsequent quarterly and current reports, filed with
the Securities and Exchange Commission. ATEC disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events,
or otherwise, unless required by law.
Investor/Media Contact:
Tina JacobsenInvestor Relations (760)
494-6790ir@atecspine.com
Company Contact:
Jeff BlackChief Financial OfficerAlphatec Holdings,
Inc. ir@atecspine.com
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