Aesculap and Invibio Partner for Knee Implant Components

Aesculap, the orthopedic unit of German medical device company B. Braun has chosen Invibio Biomaterial Solutions’ PEEK-Optima carbon fiber reinforced(CFR) polymer for its EnduRo knee revision system.

Aesculap’s device is 510(k) cleared in the United States by the U.S. Food and Drug Administration (FDA) and also has receive the CE Mark in the European Union. The device was developed to combat the predominant causes of knee implant failure, luxation, wear and poor positioning 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, according to Aesculap.

The EnduRo knee is used in the treatment of severe bone defects and ligament insufficiency. It has been commercially available in Europe since January 2010 and U.S. approval came in December 2010. A contributing factor to its fast FDA clearance-within six months of submitting the application—was Invibio’s history with implantable devices, including the amount of data provided to the submission process.

According to Aesculap, the EnduRo knee has received strong European market reception, with 14 percent market share in Germany during the first year of availability and with more than 2000 prostheses implanted to date. The first U.S. implantation of the EnduRo knee was in November 2011.

In 2010, Millennium Research Group estimated that there were more than 90,000 knee revision surgeries performed in the United States and Europe, indicating that approximately 8 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.Aesculap claims its knee`s hinge mechanism, joined cone design and the use of PEEK polymer help prevent dislocation compared to traditional hinge mechanism types that use ultra-high-molecular-weight polyethylene. PEEK Optima, however, provides greater wear and cold flow resistance as well as dimensional stability during the lifetime of the device (less than 15 years), which aids resistance to dislocation, according to the company.

“Aesculap and Invibio have benefited from a long, mutually beneficial relationship based on sharing expertise and knowledge,” said Ulf Grimm, Aesculap’s product manager for Knee Endoprostheses. “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. 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.”