WARSAW, Ind., Aug. 18, 2021 /PRNewswire/ -- Zimmer Biomet
Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology
leader, today announced U.S. Food and Drug Administration
(FDA) 510(k) clearance of the ROSA® Hip System for
robotically-assisted direct anterior total hip replacement. ROSA
Hip is the fourth robotic system introduced by Zimmer Biomet and
adds to the Company's comprehensive ROSA Robotics portfolio, which
includes the ROSA Knee System for total knee arthroplasty, ROSA
Partial Knee System for partial knee arthroplasty and ROSA
ONE® for neurosurgical and spine procedures. ROSA Hip is
the newest addition to ZBEdge, Zimmer Biomet's suite of integrated
digital and robotic technologies purposefully engineered to deliver
transformative data-powered clinical insights, shared seamlessly
across the patient journey, and with the goal of improving patient
outcomes.
"We're excited to announce the FDA clearance of ROSA Hip, and to
now offer one of the most comprehensive orthopedic robotic
solutions through a single, multiple application platform," said
Ivan Tornos, Chief Operating Officer at Zimmer Biomet. "As an
integrated component of our ZBEdge Connected Intelligence Suite,
ROSA Hip advances our vision to translate pre-, intra-and
post-operative data into actionable clinical insights to inform
personalized care decisions."
Designed to seamlessly adapt to a surgeon's existing workflow,
ROSA Hip aims to assist direct anterior surgeons with preparation,
positioning and component impaction, while intra-operatively
quantifying cup orientation, leg length and offset.
Intra-operative data collected by ROSA Hip is combined with
pre- and post-operative data collected by mymobility®
with Apple Watch®, a proprietary remote care management
platform, and it is seamlessly consolidated and analyzed by
OrthoIntel Orthopedic Intelligence Platform, which is designed to
uncover new clinical insights throughout the episode of care and
help surgeons and care teams make informed decisions and optimize
patient care.
ROSA Hip is designed for compatibility with multiple implant
systems, including the Avenir Complete® Hip System, an
evolution of the Avenir® Hip Implant that has a
clinically-proven heritage of over 10 years.1,2,3,4 The
Avenir Complete Hip System together with the
G7® Acetabular System, a comprehensive offering of
stems, shells and liners, aims to deliver greater operative
flexibility and surgical excellence to help surgeons address the
distinct needs of each patient.
"ROSA Hip will allow surgeons to retain complete control over
case planning and execution, while providing real-time data and
visualization tools," said Atul Kamath, M.D., Director, Center
for Hip Preservation at the Cleveland Clinic and a ROSA Hip
developer surgeon. "Even surgeons who are new to
robotic-assisted surgery can easily tailor ROSA Hip to adapt to
their own workflow. The robotic platform provides support
during component positioning, cup impaction and other critical
steps of an anterior approach total hip replacement. By reducing
the intra-operative variability and inconsistency, this new
technology has the potential to give surgeons and their patients
greater confidence in seeking value in contemporary total hip
replacement."
ROSA Hip is a fluoroscopy-based tool designed for surgeons who
use the direct anterior approach, a minimally invasive approach to
performing total hip replacement surgery. In addition to providing
robotic assistance to guide accurate acetabular component
orientation5, as well as intra-operative assessment of
leg length and offset, the application allows surgeons to create a
personalized surgical plan through the use of ONE Planner™ Hip.
This pre-operative planner features a spinopelvic mobility
assessment tool if both a sitting and standing lateral X-ray are
provided with the anteroposterior (AP) X-ray, together with an
auto-plan function that allows surgeons to potentially create a
pre-operative plan within five minutes. ROSA Hip may also help
improve procedural efficiency with a simplified set-up that doesn't
require pins or reference arrays and the convenient option to use
X-ray imaging instead of CT scans.
To learn more about ROSA Hip, please visit
zimmerbiomet.com/ROSAHip.
About the Company
Zimmer Biomet is a global medical technology leader with a
comprehensive portfolio designed to maximize mobility and improve
health. We seamlessly transform the patient experience through our
innovative products and suite of integrated digital and robotic
technologies that leverage data, data analytics and artificial
intelligence.
With 90+ years of trusted leadership and proven expertise,
Zimmer Biomet is positioned to deliver the highest quality
solutions to patients and providers. Our legacy continues to come
to life today through our progressive culture of evolution and
innovation.
For more information about our product portfolio, our operations
in 25+ countries and sales in 100+ countries or about joining our
team, visit www.zimmerbiomet.com or follow Zimmer Biomet on
Twitter at www.twitter.com/zimmerbiomet.
Cautionary Statement Regarding Forward-Looking
Statements
This news release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements
include, but are not limited to, statements concerning Zimmer
Biomet's expectations, plans, prospects, and product and service
offerings, including new product launches and potential clinical
successes. Such statements are based upon the current beliefs
and expectations of management and are subject to significant
risks, uncertainties and changes in circumstances that could cause
actual outcomes and results to differ materially. For a list
and description of some of such risks and uncertainties, see Zimmer
Biomet's periodic reports filed with the U.S. Securities
and Exchange Commission (SEC). These factors should not be
construed as exhaustive and should be read in conjunction with the
other cautionary statements that are included in Zimmer Biomet's
filings with the SEC. Forward-looking statements speak only
as of the date they are made, and Zimmer Biomet disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise. Readers of this news release are cautioned not
to rely on these forward-looking statements, since there can be no
assurance that these forward-looking statements will prove to be
accurate. This cautionary statement is applicable to all
forward-looking statements contained in this news release.
____________________
References
- Boisgard S, Brientini J, et al. 7-year Results of Primary Total
Hip Arthroplasty with the Uncemented Avenir Stem. Hip International
2018: 1-6. https://doi.org/10.1177/1120700018810211
- Australian Orthopaedic Association National Joint Replacement
Registry (AOANJRR). 2018 Annual Report. https://aoanjrr.sahmri.
com/ (accessed 21 March 2019).
- Endoprothesen Register Deutschland (EPRD). Annual Report, 2017.
https://www.eprd.de/de/ (accessed 21 March
2019).
- NZ Joint Registry, New Zealand Orthopaedic Association. NZJR 19
Year Report Jan 1999 to Dec 2017. https://nzoa.org.nz/nzoa-jointregistry
(accessed 21 March 2019).
- Data on File. FER-SM210407-01
Apple Watch® is a registered trademark of Apple, Inc.
ZBH-Corp
Contacts:
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Media
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Meredith
Weissman
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(703)
346-3127
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meredith.weissman@zimmerbiomet.com
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Investors
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Ezgi Yagci
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Keri
Mattox
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(617)
549-2443
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(203)
399-0856
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ezgi.yagci@zimmerbiomet.com
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keri.mattox@zimmerbiomet.com
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SOURCE Zimmer Biomet Holdings, Inc.