3D Systems Receives FDA Clearance for Vantage® Ankle PSI – Expands VSP® Surgical Planning Applications in Partnership wi...
November 17 2020 - 8:30AM
3D Systems (NYSE:DDD) today announced the Food and Drug
Administration (FDA) has provided 510(k) clearance for the Vantage®
Ankle PSI - its patient-specific total ankle surgical planning and
3D printed instruments. The product includes pre-surgical planning
and a patient-specific 3D-printed instrument set that guides
resections in the tibia and talus for total ankle replacement
surgery using Exactech’s Vantage Total Ankle System. Vantage Ankle
PSI increases operating room efficiency, reliability, and improves
soft-tissue preservation around the joint. This innovation is a
result of the collaboration between 3D Systems and Exactech
(Gainesville, Florida), a developer and producer of innovative
implants, instrumentation, and computer-assisted technologies for
joint replacement surgery.
Patient-specific orthopaedic instruments are an enabling
technology that help surgeons prepare the skeletal anatomy to
receive an implant. The Vantage Ankle PSI product, the only
solution to facilitate direct patient-specific osteotomies in the
ankle, is designed to increase surgical efficiency by allowing the
surgeon to reduce the number of steps required to prepare the
anatomy with a patient-matched 3D-printed instrument set. Features
unique to the product include a large footprint that helps to
reliably seat the guide on the bone anatomy, improved visibility to
alignment, and a corrugated design on the cutting slots that aid
surgical irrigation. This is complemented by soft tissue offsets
which are designed to preserve the periosteum, the outer fibrous
layer of the bone which aids in its healing and recovery.
“3D Systems was founded on a spirit of innovation, and we are
constantly looking for opportunities to expand the applications
that can be addressed with our VSP® surgical planning solutions to
benefit the medical community,” said Menno Ellis, EVP, healthcare
solutions, 3D Systems. “Through our collaboration with Exactech, we
drew upon our collective expertise in orthopaedics to develop an
end-to-end solution for total ankle replacements that is unique to
the market. The combination of pre-surgical planning and
3D-printed, patient-specific instruments allows the surgeon to
visualize the patient anatomy and surgical approach in three
dimensions, and then perform the surgery more efficiently with
improved surgical outcomes.”
3D Systems is recognized as a pioneer in the personalized
medicine space. The Company has manufactured more than 1 million
medical device implants and supports 85+ CE-marked and FDA-cleared
products. 3D Systems’ VSP surgical planning solutions include a
service-based approach to personalized surgery, combining expertise
in medical image processing, surgical planning, and 3D printing.
The company has a long history in surgical planning with more than
10 years of expertise in craniomaxillofacial applications. To date,
3D Systems has worked with surgeons to plan and guide more than
140,000 patient-specific procedures.
“Our collaboration with 3D Systems represents a meaningful
advancement that will accelerate the success of our Vantage Ankle
prosthesis,” said Exactech CEO Darin Johnson. “Their expertise in
surgical planning, as well as medical device design, regulatory,
and manufacturing was invaluable in developing this
patient-specific solution. The Exactech team is eager to bring this
solution to market to simplify ankle arthroplasty’s surgical
technique and enhance the patient and surgeon experience.”
3D Systems and Exactech have entered into a distribution
agreement for the Vantage Ankle PSI product offered exclusively
with Exactech’s Vantage Total Ankle System. The Vantage Ankle PSI
is currently in pilot launch with full market availability
expected in late 2021. Interested surgeons can contact their
Exactech sales representative directly, visit Exactech’s website or
join a live webinar on December 1, 2020 to learn more about this
product.
Forward-Looking StatementsCertain statements
made in this release that are not statements of historical or
current facts are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the actual results,
performance or achievements of the company to be materially
different from historical results or from any future results or
projections expressed or implied by such forward-looking
statements. In many cases, forward-looking statements can be
identified by terms such as "believes," "belief," "expects," "may,"
"will," "estimates," "intends," "anticipates" or "plans" or the
negative of these terms or other comparable terminology.
Forward-looking statements are based upon management’s beliefs,
assumptions, and current expectations and may include comments as
to the company’s beliefs and expectations as to future events and
trends affecting its business and are necessarily subject to
uncertainties, many of which are outside the control of the
company. The factors described under the headings "Forward-Looking
Statements" and "Risk Factors" in the company’s periodic filings
with the Securities and Exchange Commission, as well as other
factors, could cause actual results to differ materially from those
reflected or predicted in forward-looking statements. Although
management believes that the expectations reflected in the
forward-looking statements are reasonable, forward-looking
statements are not, and should not be relied upon as a guarantee of
future performance or results, nor will they necessarily prove to
be accurate indications of the times at which such performance or
results will be achieved. The forward-looking statements included
are made only as of the date of the statement. 3D Systems
undertakes no obligation to update or review any forward-looking
statements made by management or on its behalf, whether as a result
of future developments, subsequent events or circumstances or
otherwise.
About 3D Systems More than 30 years ago, 3D
Systems brought the innovation of 3D printing to the manufacturing
industry. Today, as the leading Additive Manufacturing solutions
partner, we bring innovation, performance, and reliability to every
interaction - empowering our customers to create products and
business models never before possible. Thanks to our unique
offering of hardware, software, materials, and services, each
application-specific solution is powered by the expertise of our
application engineers who collaborate with customers to transform
how they deliver their products and services. 3D Systems’ solutions
address a variety of advanced applications in Healthcare and
Industrial markets such as Medical and Dental, Aerospace &
Defense, Automotive, and Durable Goods. More information on the
company is available at www.3dsystems.com.
Investor Contact: investor.relations@3dsystems.comMedia
Contact: press@3dsystems.com
A photo accompanying this announcement is available
at https://www.globenewswire.com/NewsRoom/AttachmentNg/05348b3c-2bcd-4cc0-b47b-b391ddaba614
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