3D Systems Expands Orthopedic Surgical Planning Portfolio Receiving FDA Clearance for Key Ankle Indications
11 Septembre 2024 - 2:30PM
Today, 3D Systems (NYSE:DDD) announced the Food and Drug
Administration (FDA) has provided 510(k) clearance for TOTAL ANKLE
Patient-Matched Guides to be used with Smith+Nephew’s SALTO
TALARIS◊ Total Ankle Prosthesis and CADENCE◊ Total Ankle System.
The products feature individualized pre-surgical planning and a
patient-specific 3D-printed instrument set that ensures accurate
implant alignment and sizing for tailored total ankle replacement
surgery. The collaboration between 3D Systems and Smith+Nephew, the
global medical technology company, achieved these patient-matched
solutions that enable surgeons to prepare the bony anatomy of the
tibia and talus for placement of implants intended to restore
proper function of the ankle joint. These patient-matched
guides are engineered and manufactured using 3D Systems’ VSP®
surgical planning solutions that combine best-in-class digital
workflows with the industry’s broadest additive manufacturing
portfolio of printers and materials.
3D Systems’ personalized solutions are designed to
enable surgeons to capitalize on benefits such as performing the
operation with less procedural steps, shorter operating room (OR)
time,1-2 and less intraoperative x-ray radiation2 as compared to
procedures using standard non-patient-specific instruments. Ben
Johnson, 3D Systems’ vice president, portfolio & regulatory,
commented, “With over 25 years of experience, our solutions have
supported more than 175,000 patient-matched cases with the goal of
improving surgical outcomes and the overall patient experience. Our
VSP surgical planning workflow including the expertise of our
biomedical engineers, our Selective Laser Sintering technology, and
our DuraForm® ProX® PA materials is a differentiator in the market
and was instrumental in the success of this program within a short
timeframe.”
“We are excited to partner with 3D Systems and
unveil our new TOTAL ANKLE Patient-Matched Guides for total ankle
replacement — a breakthrough to help transform the way healthcare
professionals approach surgical precision and improved patient
outcomes,” said Mark McMahan, vice president of marketing, global
orthopaedics at Smith+Nephew. “This advanced system is designed to
offer unparalleled efficiency and accuracy, ultimately enhancing
the overall experience for both surgeons and patients.”
3D Systems is recognized as a pioneer in the
personalized medicine space. The Company has manufactured more than
2 million medical device implants and supported over 100
FDA-cleared and CE-marked devices. 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. As 3D Systems’ technology has evolved
over the last several years, the Company is expanding its expertise
beyond craniomaxillofacial applications to other parts of the human
skeleton such as large joints. Additionally, the Company sees
tremendous opportunity for its solutions in trauma environments
where both quality and response time are extremely important to
patient outcomes. 3D Systems’ unique additive manufacturing
solutions are helping to drive innovation in the global orthopedic
devices market that is growing at a CAGR of 11.2% and is
anticipated to reach $5.3 billion by 20233.
“3D Systems is a recognized leader in supporting
the medical device industry and surgeon community with early
adoption in craniomaxillofacial procedures,” said Gautam Gupta,
Ph.D., general manager and senior vice president, medical devices,
3D Systems. “Over the last several years, we have continued to
leverage our VSP surgical planning workflows to expand into other
personalized total joint orthopedic applications like shoulders and
ankles. Through our collaboration with an industry leader such as
Smith+Nephew, we leveraged our collective expertise in orthopedics
to develop an end-to-end solution for total ankle replacements that
is helping surgeons perform surgeries more efficiently. This is yet
another great example of how our personalized orthopedics business
continues to grow.”
3D Systems and Smith+Nephew will showcase these
guides in their respective booths — 3D Systems booth #225 and
Smith+Nephew booth #115 — at the American Orthopaedic Foot &
Ankle Society (AOFAS) Annual Meeting 2024 from September 11-14 in
Vancouver, British Columbia, Canada. For more information, please
visit 3D Systems’ website.
- Yau J, Emmerson B, et al. Patient-Reported Outcomes in Total
Ankle Arthroplasty: Patient Specific Versus Standard
Instrumentation. Foot Ankle Spec. 2024
Feb;17(1_suppl):30S-37S.
- Gauci MO. Patient-specific guides in orthopedic surgery. Orthop
Traumatol Surg Res. 2022 Feb;108(1S):103154.
- Allied Market Research, “Orthopedic 3D Printing Devices Market
Size, Share, Competitive Landscape and Trend Analysis Report, by
Type, by Application: Global Opportunity Analysis and Industry
Forecast, 2023-2032,” June 2023.
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 revise any forward-looking
statements made by management or on its behalf, whether as a result
of future developments, subsequent events or circumstances or
otherwise, except as required by law.
About 3D Systems More than 35
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.
About Smith+NephewSmith+Nephew is
a portfolio medical technology business focused on the repair,
regeneration and replacement of soft and hard tissue. We exist to
restore people’s bodies and their self-belief by using technology
to take the limits off living. We call this purpose ‘Life
Unlimited’. Our 18,000 employees deliver this mission every day,
making a difference to patients’ lives through the excellence of
our product portfolio, and the invention and application of new
technologies across our three global business units of
Orthopaedics, Sports Medicine & ENT and Advanced Wound
Management.
Founded in Hull, UK, in 1856, we now operate in
more than 100 countries, and generated annual sales of $5.5 billion
in 2023. Smith+Nephew is a constituent of the FTSE100 (LSE:SN,
NYSE:SNN). The terms ‘Group’ and ‘Smith+Nephew’ are used to refer
to Smith & Nephew plc and its consolidated subsidiaries, unless
the context requires otherwise.
For more information about Smith+Nephew, please
visit www.smith-nephew.com and follow us on X, LinkedIn,
Instagram or Facebook.
Investor Contact: |
investor.relations@3dsystems.com |
Media Contact: |
press@3dsystems.com |
Smith and Nephew (NYSE:SNN)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Smith and Nephew (NYSE:SNN)
Graphique Historique de l'Action
De Déc 2023 à Déc 2024