Patient-specific cranial implants

The BoneForm system is a custom-made medical device used to correct cranial defects through precision implants. It consists of a two-piece moulding form in which the cranial bone substitute is moulded and hardened from the bone cement in the operating room during the surgery. This substitute is designed for specific patients according their CT scans. It is also possible to order correctives for atrophic temporal muscles, skull models, or demo implants.

Why BoneForm?

  • Repeatability – In case of operative or post-operative complications (infection, trauma), the same implant can be recreated repeatedly and easily in the delivered form.
  • Antibiotic-loaded implant – Implants are moulded from bone cement (of your choice), and it is possible to use antibiotic-loaded bone cement to decrease the risk of infection.
  • Affordable solutions – Our service is more affordable than comparable solutions, and is covered by most health insurance companies (we can advise you how to incorporate this into your claim). The price is unified for all implant shapes and sizes.
  • Fast design and delivery – The implant design is completed within a few days of receiving the CT scan. The moulding form is sent within 7 days of the design’s approval by the overseeing surgeon.
  • Comprehensive and professional solution – This solution to cranial defects takes into account the condition of the whole skull as well as our experience from more than 900 cases. Each reconstruction design is approved by the treating surgeon.
  • Precision and aesthetics – The finished implant closes the defect precisely and in an aesthetically pleasing way.
  • Risk reduction for surgeons and patients – The use of antibiotic-loaded bone cement decreases the risk of infection significantly, and a precise and smooth implant does not irritate the surrounding tissues. The implant can be easily modified if something does not fit. The patient is not exposed to heat or chemicals thanks to the in-mould creation process.
  • Easy and fast use – The implant is created from bone cement quickly and easily in only 15 minutes (depends on the type of bone cement) during the surgery. The finished implant can be easily modified if necessary. Graphical instructions are included for better orientation during the surgery.
  • Correction of atrophic temporal muscle – The atrophic temporal muscle can also be corrected by an additional implant or directly through a self-cranial implant.
  • Conceptual models – A model of the patient’s skull showing the defect and a demonstration cranial implant can be sent with the moulding form if desired.

11 years of experience

900+ successful operations

70+ hospitals

5 European countries

 

Our reference centres

The University Hospital in Ostrava – Neurosurgery Clinic.

Frequently asked questions

What are your references?

We have been operating on the European market for 11 years and we have been involved in more than 900 cases.

Do you have the required qualifications for the production of medical devices?

TESCAN Medical is a registered manufacturer of custom-made medical devices in the European Union. We have the required ISO 13485 certification and first-hand experience gained over 11 years. We are using validated technologies and certified materials for the processing of CT scans and the production of medical devices.

I am interested in a cranial implant for my patient. How should I proceed?

You just have to send us an order and the patient’s CT scan. Send your order via our contact form. We will contact you after receiving your order and we will send you a link to our secure upload form for sending the CT scan.

How should I perform the CT examination to get usable data?

Slice thickness of at least 1 mm or thinner, bone reconstruction window, and without gantry tilt if possible. You can find the details in the CT scanning guidelines in the Downloads section.

How should I send you a CT scan?

We use secure data storage of medical data that conform to the highest international standards of ISO 27001, HIPAA, and GDPR. You can find necessary information about how to send us CT data by following this link.

How can I be sure that my patient and I will be satisfied with the implant?

We create the best possible implant designs based on our experience of the last 11 years. We will send the design to you electronically to get your approval, and only then will we start producing the implant. In case you want to alter the design, we will make the requested changes and then send you the new design for your approval.

How long will it take to receive the moulding form?

The implant design is completed within a few days of receiving the CT scan. The moulding form is sent within 7 days of the design’s approval by the overseeing surgeon.

What are the parts of the BoneForm system?

The delivery consists of: a sterilisable two-piece moulding form, an individualised declaration of conformity, and graphical instructions to be used to aid orientation during the surgery.

When, where, and how is the implant produced?

You create the implant easily and quickly directly in the operating room before or during surgery. Pour the mixed bone cement into the sterile moulding form, close the form, and let the cement harden. After opening the form you will find the precise and smooth implant which can be easily modified as needed. You can also use antibiotic-loaded bone cement to create the implant.

Which type of the bone cement can I use for creating the implant?

You can use low viscosity bone cement of your choice to create the implant. You can use antibiotic-loaded bone cement to decrease the risk of infection.

Some companies supply pre-prepared implants. Why should I create the implant myself during the surgery?

You can repeatedly create the same implant in our form in case of complications (infection, trauma, etc). In addition, you can use antibiotic-loaded bone cement, which significantly decreases the risk for the patient.

Where can I find all necessary information?

You can find all necessary documents and instructions in the Downloads section. We supply the instructions for use, including the sterilisation conditions, with every moulding form. The instructions include a graphical representation of the specific case for better orientation during the surgery. If desired, we can also take part in the surgery and give you the support you require.

How much does BoneForm cost?

Our service is more affordable than comparable solutions. The price is unified for all defect shapes and sizes. We provide synergy in the process of reimbursement by health insurance companies in cooperation with our local sales representatives. Please contact us for more information.

Example cases

I am interested

Do you have any questions that you didn’t find the answer to?

Look in the DOWNLOADS section or CONTACT us.