Business Overview 2006 - Synthes

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.
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