Patient Specific Implants
Patient Specific Implants and Services
Whether for reconstructive surgery or for aesthetic surgery, sometimes standard implants are not suitable or simply unavailable. For those cases, ProtoMed can help you with an implant specifically designed for your patients. The design of such a Patient Specific Implant (custom-made implant) starts from a patient’s Computer Tomography (CT) or Magnetic resonance imaging (MRI) data. In close collaboration with you, the surgeon, the design can be tuned to specific characteristics. Patient-Specific Implants ensure a fast and safe surgery resulting in a satisfied patient with an excellent aesthetic reconstruction or enhancement.
Process Workflow
Indications for a PSI
Patients Specific Implants (PSI’s) are most commonly known in the fields of Neuro- and CranioMaxilloFacial surgery. This is not surprising; in the facial region, aethetics are of vital importance. A person’s face/head is the first thing you look at and you know that first impressions count. So the Neuro and CMF field have adopted PSI’s for a combination of the 2 possible reasons for choosing a custom implant:
- Large area skull defect
- Special and complex skull defects
- Children and youth skull defects
- Patients with metal allergies
Surgical Disciplines
Cranial reconstruction after decompressive craniectomy, cerebral aneurysm procedures or meningioma resection.
Reconstruction or augmentation of skull, jaw, orbita, zygoma, maxilla,…
Reconstruction following segment resection, a comminuted fracture, revision surgery,…
For reconstructive or cosmetic purposes.
Product Advantages
Choosing Patient Specific Implants (PSI’s) has significant advantages. Mostly these advantages are born from the fact that such a custom implant fits perfectly, immediately and since it is designed for one patient, the aesthetic result is excellent .
Unique, Customized, Precise fit – Better Aesthetics
Our team at ProtoMed® is comprised of a versatile group of individuals including material, computer and mechanical engineers, and medical professionals. We use cutting edge technology to produce customized cranioplasty and maxillofacial flaps (Accuplasty®) with perfect dimensions to provide a ‘drop in fit’ to your patient’s skull/maxillofacial defect. The Polyether Ether Ketone (PEEK) 3D printer used for this can handle printing with a precision of 40 microns. We provide Implants with thicknesses of 3.5mm, 4mm, 5mm or 6mm to be patient-specific including tapering towards thin bone structures.
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Withstands Forces Better Superior Protection
In research models with quasi-static loading, PEEK cranioplasty flaps with a yield strength of 115 Mpa withstood more pressure than the native skulls. Due to its flexibility, PEEK resembles bone in mechanical properties more than titanium so that in real life, PEEK could absorb more force and be more protective against traumatic forces.
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Resembles Cortical Bone -Non-Allergenic, Lightweight,Better Comfort.
PEEK is one of the most biologically inert substances with only two reported cases7 of PEEK allergy. It has high resistance to biodegradation with lifelong performance as evidenced by increased use in spinal fusion devices. With a density of only 1.26 g/ml, custom bifrontal PEEK flaps of even 20 cm X 20 cm X 5 mm would barely weigh 250g providing more comfort to the patient. PEEK doesn’t transmit heat to brain like other metallic (titanium) implants2
Resistant to Heat and Radiation.
PEEK is a semi crystalline thermoplastic with excellent mechanical and chemical resistance properties. It has a glass transition temperature of 143 °C (289 °F) and a melting temperature of 343 °C (662 °F). PEEK is used to fabricate items which demand robustness such as bearings, piston parts, pumps and reinforcing rods. Our Accuplasty® flaps can withstand any form of sterilization from wet/dry heat sterilization to Gamma irradiation without causing any deformity.
Non-Magnetic and Radiolucent – No Artifacts in CT/MRI.
They are translucent to X-rays and nonmagnetic and do not create artifacts in CT or MR images, hence facilitating postoperative diagnostic monitoring with imaging, which is crucial in post-traumatic oncological and neurosurgical
Lowest Complication Rate – Quicker Recovery.
Long term evidence of PEEK cranioplasty shows lower postoperative complication rates following PEEK cranioplasty versus autologous grafts. Lower implant failure rates are observed with PEEK versus titanium mesh implants.
Convenient and Timely Delivery.
Being the only medical PEEK 3D printing facility in the country, we strive to deliver products at a maximum of 10 days within the country and 14 days within the region (working days, after receiving the complete set of CT images according to the required protocol and confirmed payment). You can rely on us to deliver the implants on time so you can plan the procedure at a time convenient for you and your patient.
Frequently Asked Questions
Yes and No. Since PSI’s are designed specifically for each patient, a lot of labor is involved and they cannot be mass produced; this translates to a higher initial price. However, because of the many benefits of PSI’s, they are eventually the cheaper option if you compare the total and long term costs.
Within ProtoMed we put quality upfront. we utilize state of the art materials and production processes.
We generally deliver PSIs within 10-14 days.
You will not be able to collect your PSI. Rather, we will deliver to the hospital on the surgery date via a representative.