Thornton Cleveleys, UK — Invibio®
Biomaterial Solutions, the market leader in providing PEEK-based biomaterial
solutions to medical device manufacturers around the world, announced today
that its PEEK-OPTIMA® Carbon Fibre Reinforced (CFR) polymer is utilized in
Aesculaps FDA 510k cleared and CE-Marked EnduRo knee revision system. Developed
to combat the predominant causes of knee implant failure, luxation, wear and
malpositioning associated with metal components, Aesculaps EnduRo knee
revision system relies on PEEK-OPTIMA CFR polymer to increase the implant service
life and reduce the necessity of subsequent revision surgery. Through use of
PEEK-OPTIMA CFR polymer, the service life of the EnduRo knee implant system
rotational hinge mechanisms matches that of established primary condylar
implants.
The EnduRo knee is used in the treatment of
severe bone defects and insufficiency of the ligamented apparatus. It has been
commercially available in Europe since January
2010 and received FDA 510k clearance in December 2010 – only 6 months after
submission.
A contributing factor to its fast FDA
clearance time is Invibios accomplished history of use in FDA-cleared long
term implantable devices and the wealth of data Invibio provides to support
companies through their submission process. According to Aesculap, the EnduRo
knee has received strong European market reception, gaining a 14% market share
in Germany
during the first year of availability and with more than 2000 prostheses
implanted to date. Whilst in the US, Aesculap received a strong
launch into the market with the first implantation of the EnduRo knee in
November 2011.
In 2010, Millennium Research Group
estimated that there were more than 90,000 knee revision surgeries performed in
the US and Europe, indicating that some eight percent of all knee implant
procedures result from failure of the initial knee implant. A contributing
factor to these failures is dislocation, whereby the rotational axis slips out
of its guide, requiring total replacement of the implant. EnduRo knee`s
innovative hinge mechanism, joined cone design and the use of PEEK-OPTIMA CFR
polymer are intended to prevent dislocation compared to traditional hinge
mechanism types that use UHMWPE. PEEK-OPTIMA CFR provides greater wear and cold
flow resistance as well as dimensional stability during the lifetime of the
device (>15 years), which aids resistance to dislocation.
According to Dipl.-Ing. (FH) Ulf Grimm,
Aesculap Product Manager for Knee Endoprostheses, PEEK-OPTIMA CFR provides
valuable surgeon and patient benefits, including:
- Proven biocompatibility and biostability
that provides safety and implant longevity; - Flexural strength similar to the cortical
bone thus reducing stress shielding and improving patient comfort; - Excellent wear performance and creep
resistance to prevent dislocation; - Processing and design flexibility that
assists surgery planning and enhances patient mobility; and, - History of use in FDA approved long term
implantable devices for both patient and surgeon reassurance.
In addition to providing significant
patient benefits over primary condylar implants, the EnduRo knee design extends
surgical options and minimizes complexity. For example, using the EnduRo system
cone connector to link the rotational axis and hinge ring of the femoral
component, surgeons can eliminate the need for condylar drilling. This, in
turn, minimizes the risk of ligament and soft tissue trauma.
“Aesculap and Invibio have benefited from a
long, mutually beneficial relationship based on sharing expertise and
knowledge. It was through technical expertise, an understanding of our
requirements and a long history of proven biocompatibility and implantation
success that Invibio was able to provide us with an exceptional solution,”
stated Herr Grimm.
“Throughout this process Invibio has
provided valuable processing support and a manufacturing network with the
flexibility and scope to meet our device and time targets. Working with Invibio
provided us with both a material and processing solution package that enabled
our accelerated time to market requirement,” he added.
About Invibio
Invibio is a global leader providing high performance biomaterials, advanced
technical research and consultative solutions to medical device manufacturers
across a wide range of markets. The company provides medical device
manufacturers with PEEK-OPTIMA polymer and compounds, MOTIS® polymer, ENDOLIGN®
composite and PEEK-CLASSIX® polymer for the development of long- and short-term
implantable medical devices.
Please contact Invibio at: +484 342
6004 (Americas),
+44 (0) 1253 898 000 (Europe & Asia Pacific), info@invibio.com, or visit www.invibio.com for more information.
About Aesculap Division
Aesculap, a division of one of the worlds leading healthcare suppliers B.
Braun Melsungen, stands for quality and innovation. With an international
service network, Aesculap focuses on products and services for all of the core
processes in surgery. Whilst their product catalogue ranges from surgical instruments
for open to minimally invasive approaches through to implants for orthopaedic,
neurosurgery and spinal surgery. Aesculap places strict demands on product
safety and quality, providing reliable products and services to the global
market.
Please contact Aesculap at: (0049) 7461 95
0, info@aesculap.de, or visit www.aesculap.com for more information.
Posted by Sean Fenske, Editor-in-Chief, MDT