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| File | Fileinfo | Date | Filesize | |||
 | | Download PDF | | 19.11.07 | | 67 KB |
Synthes Receives FDA Clearance for chronOS™ Strip Flexible Ceramic Osteoconductive Bone Void Filler
Solothurn/Switzerland, November 20, 2007
Synthes today announced the recent FDA 510(k) clearance of chronOS™ Strip for use in the spine for posterolateral fusions. chronOS Strip is expected to broaden the already successful chronOS line of synthetic ceramic bone graft substitutes.
chronOS Strip is designed to fill bony voids or gaps that are not intrinsic to the stability of the bony structure; such voids can be the result of a surgical procedure or traumatic injury. This new biomaterial offers surgeons increased handling options and leverages two areas of expertise for Synthes: osteoconductive ceramics and resorbable biocompatible polymers. The unique combination of these two materials into one implant offers surgeons a 100% synthetic composite graft containing no human or animal derived materials. chronOS Strip can be rolled, folded, cut or sutured intraoperatively, and then conformed to each patient’s anatomy.
The perfusion of chronOS Strip with bone marrow aspirate provides a favorable environment for bony ingrowth. To facilitate this, each strip is sterile packaged in a perfusion pack that allows easy perfusion and homogenous saturation with the patient’s bone marrow and/or blood. The perfusion pack can be connected to any standard syringe, such as the one found in the Synthes Bone Marrow Aspiration System. chronOS Strip may also be used in conjunction with autograft.
chronOS Strip is replaced with new bone in 6 - 18 months during the bone remodeling process, and the uniform, three-dimensional pore structure of the imbedded chronOS granules provides an ideal matrix for the ingrowth of bone. The Synthes chronOS line of 100% synthetic bone void fillers provides surgeons with excellent options for their bone grafting needs.
Synthes: A leading medical device company
Synthes is a leading global medical device company. We develop, produce and market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.
For further information please contact
Gilgian Eisner, Investor Relations, Synthes, Inc.
Phone +41 32 720 47 45, Fax +41 32 720 48 11,
e-mail: ir.info@synthes.com