ROCK HILL, S.C., Sept. 26, 2019 /PRNewswire/ -- 3D
Systems (NYSE: DDD) announced that the Food and Drug
Administration (FDA) has provided 510(k) clearance to its new
VSP Orthopaedics solution -- enabling surgeons to obtain a clear 3D
visualization of a patient's anatomy and develop a personalized
surgical plan, prior to entering the operating room. The
expansion of 3D Systems' VSP service-based approach into the field
of orthopaedic surgery builds on its VSP technology and anatomic
modeling leadership – having helped with more than 120,000 unique
patient cases in its 25 years of experience.
The new VSP Orthopaedics solution is available exclusively
through Onkos Surgical's My3D™ Personalized Solutions
Platform and enables surgeons to devise a precise plan
for tumor resection that in some cases allows for the preservation
of the native joint. Virtual surgical planning of the patient's 3D
anatomy, allows the surgeon to essentially perform the surgery
digitally before entering the operating room. Following the online
planning session between 3D Systems' biomedical engineers and the
surgeon, patient-specific models, personalized surgical tools, and
instruments are designed and 3D printed for use within the sterile
field. In clinical applications where VSP is used today, the
solutions have been shown to improve surgical accuracy and outcomes
-- saving time in the operating room which benefits both the
surgeon and the patient.1,2,3 3D Systems fully
expects that VSP Orthopaedics will deliver the same benefits to
Orthopaedic surgeons and patients.
"Throughout the years, the power and innovation of our VSP
solutions has been demonstrated through improved patient outcomes
in a variety of surgical specialties," said Radhika Krishnan, senior vice president,
software & healthcare, 3D Systems. "Our 3D printing
technologies combined with the renowned expertise of our biomedical
engineers, in collaboration with surgeons, can have a positive
impact on a patient's life -- even before they ever enter the
operating room. Based on the success we've seen with our
personalized healthcare solutions in other surgical specialties, we
are confident in the positive impact on patient care this
technology will have for the orthopaedic community. The
opportunity to leverage our capabilities with Onkos' passion for
providing differentiated solutions for oncologists will translate
into meaningful innovation for musculoskeletal oncology surgeons
and patients."
As a pioneer in the personalized medicine space, 3D Systems
established VSP in 2012 as a service-based approach to personalized
surgery, combining expertise in medical image processing, surgical
planning, design, and 3D printing.
"As an early stage investor in Onkos, 3D Systems understands our
passion for developing innovation," said Patrick Treacy, CEO, Onkos Surgical. "The VSP
Orthopaedics System, which is available exclusively through our
My3D Personalized Solutions platform is a great example of how
we're harnessing the power of advanced surgical planning and
personalization to create novel solutions that musculoskeletal
patients deserve."
For more information, please visit www.3dsystems.com.
Forward-Looking Statements
Certain statements made in
this release by or in reference to 3D Systems 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 3D Systems' periodic filings with
the U.S. 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 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 AM solutions company, it empowers
manufacturers to create products and business models never before
possible through transformed workflows. This is achieved with the
Company's best-of-breed digital manufacturing ecosystem - comprised
of plastic and metal 3D printers, print materials, on-demand
manufacturing services and a portfolio of end-to-end manufacturing
software. Each solution is powered by the expertise of the
company's application engineers who collaborate with customers to
transform manufacturing environments. 3D Systems' solutions address
a variety of advanced applications for prototyping through
production in markets such as aerospace, automotive, medical,
dental and consumer goods. More information on the company is
available at www.3dsystems.com.
- Sink J, Hamlar D, Kademani D, Khariwala SS: Computer-aided
stereolithog-raphy for presurgical planning in fibula free tissue
reconstruction of the mandible. J Reconstr Microsurg 28:395-404,
2012
- Patel A, Levine J, Brecht L, Saadeh P, Hirsch DL: Digital
technologies in mandibular pathology and reconstruction.
Atlas Oral Maxillofacial Surg Clin N Am 20:95-106, 2012
- Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW,
Christensen AM, Weimer KA, Steed MB: The accuracy of virtual
surgical planning in free fibula mandibular reconstruction:
comparison of planned and final results. J Oral Maxillofac Surg
68:2824-2832, 2010
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SOURCE 3D Systems