Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite
June 13 2019 - 11:32AM
Business Wire
Introductory Workflow, Mimics Enlight Mitral provides support
for transcatheter mitral valve replacements
TVT2019 – Structural Heart Summit -- Materialise (NASDAQ:MTLS),
a global 3D printing software and solutions company, has received
FDA clearance for its Mimics Enlight cardiovascular planning
software suite. The first release will support clinicians planning
complex transcatheter mitral valve replacement (TMVR)
procedures.
Mimics Enlight is based on the strengths of Materialise’s Mimics
Innovation Suite, which has helped clinicians produce
patient-specific 3D models for more than 20 years. Created in
collaboration with Henry Ford Health System in Detroit with Dr. Dee
Dee Wang, MD, FACC, Director of Structural Heart Imaging, and
leveraging the Henry Ford Innovation Institute’s patented workflow,
Mimics Enlight is intended to support patient selection and
planning for structural heart and vascular therapy. The software is
the first of its kind to include consistent methods of taking
critical measurements. This enables clinicians to reliably plan and
screen patients for cardiovascular procedures. The TMVR workflow
provides a streamlined, easy-to-use clinical workflow for planning
complex procedures to correct mitral regurgitation, a disease
affecting nearly one in 10 people age 75 and older.
“We believe in the power of our mission to create a better and
healthier world,” said Bryan Crutchfield, vice president and
general manager of Materialise North America. “We work very closely
with teams at our partner hospitals and medical device companies to
identify areas where 3D planning and printing can improve their
ability to plan procedures. With the FDA clearance of Mimics
Enlight, we are expanding the 3D toolkit for cardiologists working
to treat patients with complex cardiovascular issues, starting with
mitral valve replacement.”
Each mitral valve replacement differs due to a patient’s unique
anatomy, making procedural planning crucial to the successful
implantation of TMVR devices. Accurate measurements during planning
are vital for predicting patients’ risk for left ventricle outflow
track (LVOT) obstruction, a complication resulting in obstruction
of blood flow out of the left ventricle to the rest of the
body.
“Materialise has a wealth of medical technology and experience
built throughout two decades of development and implementation of
the Mimics Innovation Suite,” said Brigitte de Vet-Veithen, vice
president of Materialise Medical. “That expertise in delivering
patient-specific solutions serves as the foundation for Mimics
Enlight Mitral’s ability to consistently view and measure each
patient’s complex mitral valve anatomy. Using a 3D model created in
Mimics Enlight Mitral improves physicians’ ability to understand
and plan procedures before entering the cath lab and gives them the
reliable measurements critical to successful implantation of TMVR
devices in highly diseased hearts.”
Leveraging Materialise’s expertise in creating accurate
patient-specific 3D anatomical models, Mimics Enlight Mitral gives
clinicians accurate 3D models for consistency in taking
measurements like Neo-LVOT to screen patients for TMVR therapy,
plan procedures and determine the appropriate size and positioning
of TMVR devices.
Materialise, a leader in software solutions and 3D printing
services in the medical and industrial markets, helps medical
professionals improve procedural planning and communications
through innovative 3D solutions. With Mimics Enlight, clinicians
and hospitals will be able to scale their 3D modeling solutions for
cardiovascular procedures, knowing they are working with a trusted
partner in the medical device field.
Learn more about the Mimics Enlight Software from the
Materialise medical team at the Transcatheter Valve Therapies
TVT2019 – Structural Heart Summit in Chicago June 13-15, 2019.
About MaterialiseMaterialise incorporates nearly three
decades of 3D printing experience into a range of software
solutions and 3D printing services, which together form the
backbone of the 3D printing industry. Materialise’s open and
flexible solutions enable players in a wide variety of industries,
including healthcare, automotive, aerospace, art and design, and
consumer goods, to build innovative 3D printing applications that
aim to make the world a better and healthier place. Headquartered
in Belgium, with branches worldwide, Materialise combines the
largest group of software developers in the industry with one of
the largest 3D printing facilities in the world. For additional
information, please visit: www.materialise.com.
Cautionary Statement on Forward-Looking StatementsSome of
the statements in this press release are "forward-looking" and are
made pursuant to the safe harbor provision of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include statements relating to, among other things, our
planned commercialization efforts and regulatory approvals of our
technologies as well as the success thereof and our research and
development projects. These forward-looking statements are based
upon the expectations of management under current assumptions at
the time of this press release. We caution you that forward-looking
statements are not guarantees of future performance and involve
known and unknown risks, uncertainties and other factors that are
in some cases beyond our control that may cause our actual results
to differ materially from our expectations. We are providing this
information as of the date of this press release and do not
undertake any obligation to update any forward-looking statements
contained in this presentation as a result of new information,
future events or otherwise, unless we have obligations under the
federal securities laws to update and disclose material
developments related to previously disclosed information.
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Press contacts:Virginia GobleMaterialisePhone:
734.259.6445Mobile : 248.921.5500Email:
virginia.goble@materialise.comTwitter: @MaterialiseNVVisit:
www.materialise.com
Dan HornFrancoPhone: 313.567.5008Mobile: 313.410.3992Email:
horn@franco.com
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