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Sulzer Calcitek Announces the Limited Market Evaluation of the Spline™ CSTi Dental Implant

CARLSBAD, California – Sulzer Calcitek Inc., the dental implant company of Sulzer Medica, has begun a limited market evaluation of its Spline CSTi dental implant, an innovative new dental implant design. The Spline CSTi implant design is a result of the combined efforts of Sulzer Calcitek and Sulzer Orthopedics Inc., the Austin, Texas-based reconstructive orthopedic business of Sulzer Medica. CSTi (Cancellous Structured Titanium) is a proprietary porous metal coating that has a long history of clinical success on orthopedic implants manufactured by Sulzer Orthopedics.1 It encourages implant integration by allowing healthy bone to grow into the coating pores, forming a very stable implant/bone interface.1,2 Sulzer Calcitek and Sulzer Orthopedics have worked together since 1992 to adapt this coating to dental implants. The culmination of that work is the Spline CSTi implant.

The U.S. Food and Drug Administration (FDA) recently cleared the Spline CSTi implant to market. Final pilot production at Sulzer Orthopedics' Austin facility is complete and the plant is currently producing implants to be used during the evaluation.

With interviews completed and the sites selected, the evaluation is ready to begin. "We've lined up three prestigious evaluation sites with well-respected clinicians heading up each investigative team," said Steven E. Hanson, Sulzer Calcitek's president. The evaluation will be conducted by: New York University College of Dentistry, Dennis P. Tarnow, DDS; Harvard School of Dental Medicine, Joseph P. Fiorellini, DMD, DMSc; and Coastal Jaw Surgery, The Center for Dental Implant, Facial and Oral Reconstruction, Palm Harbor, Florida, Michael A. Pikos, DDS, Founder.

Plans for full commercial introduction are being developed by Sulzer Calcitek.

Sulzer Medica is a global company focused on the development of implantable medical devices and biomaterials for the cardiovascular and orthopedic markets worldwide. The company's products and services include heart valves, pacemakers, defibrillators, ablation catheters, vascular grafts, artificial knees, hips, shoulders, and dental implants. Sulzer Medica (NYSE: SM and Zurich Stock Exchange: SMEN).

1Data on file.
2Results from animal studies can not be directly correlated to results in humans.
Spline is a trademark of Sulzer Calcitek Inc.

Spline Dental Implant System is protected by U.S. Patent No. 5,449,291. A219 9/97 [ Printer-friendly page Printer-friendly page ]
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