17 September 2024
Victrex
plc
US FDA Approval for Total
Knee Arthroplasty Study in the US
Victrex plc is an innovative world
leader in high performance polymer solutions, delivering
sustainable products which support CO2 reduction and enable
environmental and societal benefit in multiple
end-markets.
The Group today announces that, in
partnership with Maxx Orthopedics Inc, the U.S. Food and Drug Administration (FDA) has granted
Investigational Device Exemption (IDE) approval for Freedom® Total
Knee System with Invibio PEEK-OPTIMA™ Femoral Component, as a
staged study. The study, projected to be 120 patients at clinical
sites in the US, will compare using the PEEK-OPTIMA™ Femoral Knee
Component to a controlled registry of the same system using
traditional metal femoral components.
The US study will build on the
existing clinical trial for PEEK Knee at sites in Belgium, India
and Italy, which has been progressing strongly since the first
implant in 2021, with no clinical intervention. A regulatory
submission in India is also expected imminently, supporting the
potential for a commercial PEEK Knee in the market in
2025.
Jakob Sigurdsson, Chief Executive of
Victrex, said: "PEEK Knee has the potential to be a game-changer
for total knee replacement. Being able to further assess its
benefits through rigorous clinical evaluation in the US will build
on the strong progress so far through clinical trial sites in
Europe and India. We look forward to the study's progression and
remain optimistic about the transformative impact this pioneering
device could have on the future of joint replacement.
"In relation to the regulatory
submission in India, following a tenacious focus on innovation,
development and investment to scale this significant opportunity,
we now look forward to the potential for a PEEK Knee being in the
market during 2025 and commercial revenues. We also continue to see
growing interest in PEEK Knee from across the medical device
industry, beyond our existing collaborations."
Victrex plc:
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Andrew Hanson, Director of Investor
Relations, Corporate Communications & ESG
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+44 (0) 7809 595831
|
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Jakob Sigurdsson, Chief
Executive
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+44 (0) 1253 897700
|
|
Ian Melling, Chief Financial
Officer
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+44 (0) 1253 897700
|
About Victrex:
Victrex is an innovative world
leader in high performance polymer solutions, focused on the
strategic markets of Automotive, Aerospace, Energy &
Industrial, Electronics and Medical. Every day, millions of people
rely on products or applications which contain our sustainable
materials, from smartphones, aeroplanes and cars to oil & gas
operations and medical devices. With over 40 years' experience, we
are moving beyond the polymer into semi-finished and finished
products which shape future performance for our customers and our
markets, enable environmental and societal benefit for our
customers and drive value for our shareholders. Find out more
at www.victrexplc.com