Synthes-Stratec announces FDA notification that it may begin the ProDisc® Cervical-C IDE disc replacement clinical trial
Oberdorf/Switzerland, July 30, 2003
Synthes-Stratec announced today that Spine Solutions, Inc. (SSI), a wholly owned subsidiary, received FDA notification on July 23, 2003 that it may begin the ProDisc® Cervical IDE disc replacement clinical trial study. Implantations could begin as early as the 3rd Quarter of 2003.
Spine Solutions, Inc., which was acquired by Synthes-Stratec in April 2003, is the developer and marketer of this revolutionary and unique total artificial disc system designed to significantly reduce spinal disorders and back pain and restore mobility to the lumbar and cervical spine after surgery.
The ProDisc® system (lumbar and cervical artificial discs and instrumentation), which is made of proven materials with more than a 20 year history of use in hip and knee replacement, was first developed by Dr. Thierry Marnay in the late 1980s. It was subsequently refined in close cooperation with Aesculap AG.
The ProDisc® system could transform spine surgery by replacing a high percentage of spinal fusion procedures for both the lumbar and cervical spine with disc replacement procedures. One of the significant competitive advantages of the ProDisc® system is that the design of the instrumentation is less invasive and offers a surgical procedure which is easy-to-learn, benefits the patient, and is user friendly to surgeons.
To date, SSI has obtained CE Mark approval in Europe. Through various distributors, Spine Solutions is currently selling the ProDisc® system throughout 26 countries in Europe, Asia Pacific, Latin America and South Africa. The ProDisc® system, which has been evaluated in a retrospective clinical study of 64 patients dating back more than 10 years with excellent follow-up results, has now been implanted in more than 3,800 patients worldwide.
The company believes the global market potential for total disc replacement (spine arthroplasty) will grow to $ 3 billion by 2008.
Spine Solutions is one of only two companies which is currently conducting an FDA approved multi-center pivotal IDE study for a lumbar total disc replacement. The company expects, data permitting, a final FDA approval within a reasonable timeframe based on the large number of patients already treated with the ProDisc® system.
Synthes-Stratec – A leading orthopaedic trauma and spine company
Synthes-Stratec is a leading provider of instruments, implants and power tools for the orthopaedic trauma market. The company develops, manufactures, and distributes products for the surgical treatment of bone fractures, maxillofacial trauma or deformities, and a full range of products and systems for spine surgery.
For further information please contact
Peter Fehlmann, Investor Relations, Synthes-Stratec, Inc.
Phone: +41 61 965 63 39, Fax: +41 61 965 66 06, e-mail: ir.info@synthes.com