Last December, the first AccuShape cranial implant was used to treat the stroke patient in Florida. The patient had a serious skull defect and required a cranioplasty. The patient-specific AccuShape PEEK plate was the first produced by MedCAD since the company received their 510k FDA approval in October. The manufacturing process was controlled by neurosurgeon Dr. David Greenwald. The implant was designed with regard to the individual anatomic characteristics of the patient alongside digital surgical planning, computer tomography scan results and three-dimensional modeling. The components of the planning and design process helped produce a PEEK plate that ideally fit the defect. The implant made it possible to reconstruct the skull shape of the stroke patient and achieve the expected result.
The advanced AccuShapeTM implant differs significantly from other skull reconstruction methods that are traditionally applied during such surgical interventions. The most popular methods are hand-made cranial implants and bone grafts. These options have always been associated with a number of disadvantages, such as the incorrect fit, increased patient risks, prolonged surgical time, bone graft resorption, numerous surgical sites, and the need for consequent surgeries. The use of MedCAD’s PEEK cranial implant has minimized the risks, offering the most adequate cranial reconstruction solution. Additionally, AccuShape is ideal for post-operative imaging as biocompatible PEEK plating is radiolucent. The material is also steam utoclavable, gamma radiation resistant, and comparable to cortical bone.
Regarding the stroke patient in Florida, the MedCAD specialists used the mirror image of the healthy side of their skull to make the 3-dimensional implant modeling a success, ideally fitting the defect area. The fabrication of the implant was made with precision machining of PEEK thermoplastic and verified by matching the implant with a 3D printed model. PEEK material differs from traditionally used bone grafts as it is not absorbed by the body and is more durable. As a result, both Dr.Greenwald and his patient were satisfied with the quality and design of the implant for the cranial reconstruction procedure.
Similarly, a customized AccuShape PEEK implant was received by another patient – Gabrielle Giffords, the Congresswoman, who survived after a gunshot to the head in January of 2014. You can find out more about the case and see the sample of the implant.
MedCAD is a world-renowned provider of customized medical services and devices that feature patient-specific product lines. The company has years of experience in developing custom surgical solutions helping hundreds of surgeons across the globe develop more advanced and detailed surgical plans. Currently, MedCAD is looking for corporate relationships with distribution partners interested in the advancement of PEEK implants, surgical planning, and 3D models.