Feb 12 2012 Press release

Invibio PEEK-OPTIMA polymer used in Aesculap FDA 510k cleared EnduRo Rotational Knee System

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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 fiber Reinforced (CFR) polymer is utilized in Aesculap’s FDA 510k cleared EnduRo knee revision system.

Aesculap’s EnduRo knee system was designed for patients needing a knee implant revision due to a failed arthroplasty. In 2010, Millennium Research Group estimated 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.

The EnduRo knee is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. Hinge knee systems are designed for use in patients in primary or revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments are absent for insufficient. The femoral and tibial augments are to be attached to their respective components with a fixation screw or screws. The EnduRo Knee System is intended for cemented use only. It has been commercially available in Europe since January 2010 and received FDA 510k clearance in December 2010.

Invibio has an accomplished history of use in FDA-cleared long term implantable devices and provides a wealth of data 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. While in the US, Aesculap’s EnduRo knee was launched into the market with the first implantation in November 2011.

Valuable Surgeon and Patient Benefits
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.

“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 Ulf Grimm, Aesculap Product Manager for Knee Endoprostheses.

“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.
Invibio PEEK-OPTIMA CFR provides essential attributes required for long-term implantable medical devices, including:

  • Proven biocompatibility and biostability
  • Flexural strength similar to the cortical bone
  • Processing and design flexibility
  • History of use in FDA cleared long term implantable devices

About Aesculap Implant Systems, LLC
Aesculap Inc., a B. Braun company, founded in 1867 in Tuttlingen, Germany, is the world’s largest and one of the most respected manufacturers of surgical instruments and sterilization container. Aesculap is a leading privately-owned manufacturing company, passionately committed to providing high-quality, innovative products and services to all surgical disciplines, with particular focus in the fields of General, Neuro, Spine and Orthopaedics.

Aesculap Implant Systems, LLC, established by Aesculap, Inc. in 2005, focuses on delivering innovative solutions to the spine and orthopaedic markets. Aesculap Implant Systems maintains a surgeon/patient focus with the goal of improved operative procedures and patient outcomes leading to an improved quality of life. For more information about Aesculap Implant Systems or its medical products, call 800-234-9179, email us at info@aesculap.com or visit www.AesculapImplantSystems.com.

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 constraint s or difficulties; product development, commercialization 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.

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) visit www .invibio.com for more information.

Invibio Media Contact:
Susan Skrudland
marketing@invibio.com
+1 224-764-2125

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