Sulzer Medica Cleared to Market Polyethylene for Orthopedic Implant Applications

Sulzer Medica (Winterthur, Switzerland and Houston, TX) announced that its subsidiary Sulzer Orthopedics (Austin, TX) has received FDA clearance for the commercial release of Durasul polyethylene, a wear-resistant material for orthopedic implant applications.

Polyethylene is used in many joint implants for acetabular inserts. Durasul polyethylene's increased crosslinked density, according to data from hip simulator wear tests, reduces wear between polyethylene acetabular inserts and cobalt-chrome heads to unmeasurable levels compared to polyethylene conventionally used for orthopedic hip implants.

In December 1997, Sulzer Orthopedics entered into a licensing agreement with Massachusetts General Hospital (MGH) and the Massachusetts Institute of Technology (MIT) for worldwide rights to produce and market Durasul polyethylene. It was developed as a joint project of the Orthopaedic Biomechanics Laboratory at MGH, under the direction of William H. Harris, MD, and the MIT, through the contributions of Professor Ed Merrill and the research and development group of Sulzer Orthopedics.

"This new polyethylene process addresses the issue of implant durability. According to very extensive and thorough laboratory testing, the outlook for major advances in total hip arthroplasty worldwide with Durasul polyethylene is very high," said Dr. Harris, world-renowned orthopedic surgeon and director of MGH's research laboratory.

In the United States, Sulzer Orthopedics will market Durasul acetabular inserts for use in the Inter-Op Acetabular System shells.

Durasul polyethylene will be launched in Europe on June 5, 1999. Components will be distributed in European countries later this year.

Sulzer Medica is focused on the development of implantable medical devices and biomaterials for the cardiovascular and orthopedic markets worldwide. The company's products include artificial joints, spine and dental implants, products for traumatology and arthroscopy, heart valves, and vascular grafts.