Business Overview 2006 - Synthes

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Product Highlights. Cranio-maxillofacial. Cranio-maxillofacial. Patient Specific Implants In cranioplasty, a satisfying aesthetic result is essential. Synthes Patient Specific Implants are custom-designed implants for the treatment of skull defects and deformities. Because the implants are derived from the patient’s CT data, excellent reconstructive results are achieved. Cranioplasty, the surgical repair of defects or deformities of the skull, is a challenging field. Cranioplasties can treat a variety of conditions ranging from head trauma to the removal of a tumor, with the goal of achieving full functionality and acceptable cosmesis. The challenge for craniofacial surgeons and neurosurgeons alike is to restore the skull completely using an implantable material and a surgical technique that minimize post-operative complications. Ideally, the material should mimic the properties of craniofacial or cranial bone in terms of strength, infection resistance and fracture resistance to name just a few. 3-D model derived from CT scan data PSI custom made to fit defect Previous solutions with drawbacks There is currently a multitude of materials surgeons can choose from for treating skull defects or deformities, including autogenous bone, metals and alloplastics. Autogenous bone grafting, where the patient’s own bone is used, has long been the standard in reconstructing the craniofacial skeleton. However, this method is often associated with significant resorption and is prone to high levels of infection. Metals, mainly titanium and titanium alloys, offer high strength characteristics relative to cranial bone and are unlikely to harbor infection, but they are not easily contoured to match the patient’s anatomic features, especially for larger defects. Alloplastics, or moldable plastics, are popular for their adaptability, but they are prone to infection, cannot always be molded easily for large defects, and give off tremendous heat during the application process. Innovative, custom-designed implant With the introduction of Patient Specific Implants (PSI) Synthes offers the solution to many of the challenges associated with cranioplasty. PSIs are implants that are custom-designed for each patient and replace bony voids in the cranial and craniofacial skeleton. Each implant is designed using a 3D computer-aided design (CAD) model derived from the patient’s CT scan and is approved by the surgeon prior to production in order to ensure a high-quality final product. The featured benefits of this product compared to the conventional treatment options include a better anatomic fit and reduction in operating time. Synthes offers two biocompatible material options for PSIs, PEEK Optima-LT and commercially pure titanium. Both are non-porous materials and neither is known to harbor infection. PEEK Optima-LT has bone-like properties in terms of strength and stiffness and is the material of choice for Synthes surgeons. This lightweight plastic offers no limitations in plating orientation or location and can, if necessary, be modified in shape at the time of the surgical procedure. Implants made from titanium have ultra-high strength as compared to cranial and craniofacial bone. These metallic implants require predetermined machine screw locations for the attachment of plates and cannot be modified intraoperatively. A strong solution for aesthetic results One of the main advantages of these custom implants is that they achieve the intended corrective result while minimizing operating time. Moreover, post-operative complications are reduced and even prevented by using proven biocompatible materials such as PEEK and titanium. Together, these benefits make PSIs a strong solution: they reduce medical costs, facilitate a rapid recovery, and – most importantly – fully restore the patient’s anatomical cosmesis and functionality. 24
Synthes. Annual Report 2006 Patient story | Diagnosed with an intracranial tumor, this 42-yearold man decided to have it surgically removed. The surgeon resected the tumor, replaced the native bone flap and fixated it with plates and screws. Due to intracranial swelling, the patient suffered from a seizure two years later and the bone flap and hardware were permanently explanted. During his recovery, the CT scan was evaluated for a Synthes Patient Specific Implant. Later that year, the patient had a cranioplasty in which a PSI made of PEEK was implanted. Extremely happy with the result, he has healed well and is back to normal everyday life. After removal of native bone flap 2 months after treatment 25
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Business Overview 2006 - Synthes

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