Innovative system can extend service life and reduce the necessity of subsequent revision surgery
Thornton Cleveleys, UK (For Non-US Distribution) – 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 Aesculap’s EnduRo knee revision system. Developed to combat the predominant causes of knee implant failure, luxation, wear and malpositioning associated with metal components, Aesculap’s 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 Invibio’s 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 8% 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
- 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 minimises 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, minimises 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 Aesculap Division
Aesculap, a division of one of the world’s 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.
Forward looking statements
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as “anticipate,” “believes,” “estimate,” “expect,” “should,” “intend,” “projects,” “objective” and “appears” and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company’s management, as well as assumptions made by and information currently available to the Company’s management. Among the factors that could cause actual results to differ materially are especially but not limited to the following: the effect of business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialisation or technological difficulties; the regulatory and trade environment; the impact of reimbursement rates and coverage; and the risk factors reported from time to time in the Company’s SEC reports. All forward looking statements included in this release are made only as of the date of this release; therefore the Company undertakes no obligation to revise any forward-looking statements as a result of future events or developments.
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.