KBSU Modifies Implant Material—It Can Replace Titanium and Will Be Covered by Compulsory Medical Insurance

Scientists at the Kabardino-Balkarian State University named after Kh.M. Berbekov have modified a polymer for medical implants that can replace titanium plates. The material is undergoing the registration process with Roszdravnadzor for practical use. The implants will be covered by compulsory medical insurance.

The Center for Advanced Materials and Additive Technologies at Kabardino-Balkarian State University has been manufacturing surgical guides from polymers for approximately 10 years. These guides are most often used for patients undergoing tumor removal or for those injured in traffic accidents. The university has improved the structure of polyetheretherketone (PEEK), a super-strong material capable of replacing titanium. By introducing copolymers, the researchers achieved stable printing at lower temperatures and virtually eliminated critical shrinkage, which could cause product deformation. This allows for the use of more accessible equipment and 3D printing techniques for hospitals using newly developed biocompatible materials.

Creating a digital 3D model takes 30-60 minutes. Scientists upload CT scan data into specialized software, and the operator manipulates the 3D model, taking into account the doctors’ preferences. The file is then sent to the 3D printer and then to the operating room. The entire production cycle, after receiving registration certificate, will reduce the waiting time for the patch and the surgical procedure itself. Using 3D modeling based on personalized CT scan data for the patient enables high precision and facilitates the work of doctors. Moreover, the material is biocompatible and does not react chemically with tissue.

«Extensive skull defects are very difficult to repair. For these, flat titanium plates are more often used, which are difficult to reshape the head so that it remains symmetrical after surgery,» explains Azamat Khashirov, senior researcher at the Center for Advanced Materials and Additive Technologies at KBSU. «Polymer materials can replace titanium and directly print implantable patches on a 3D printer. The structure can be made more porous, allowing for better cell growth and more effective engraftment. This can reduce recovery time for patients.

Titanium surgical patches require manual adjustment, are uncomfortable at low temperatures, and don’t always engraft. Furthermore, metal is stiffer, while polyetheretherketone is elastic and provides shock absorption during physical activity. The estimated cost of polymer implants is lower than imported equivalents, which can cost up to a million rubles.

«The price of a PEEK-based product will be comparable to a titanium solution and will be covered by compulsory medical insurance. Obtaining a registration certificate will allow us to implement this innovation not only in our republic but throughout the country,» emphasized Azamat Khashirov.
The implants have undergone a full cycle of preclinical animal testing. Laboratory rats underwent craniotomy and a PEEK patch was installed. The rodents’ behavior and tissue condition were then monitored. Tests showed no abnormalities in the subjects’ bodies.

At this stage, the process of obtaining a registration certificate from Roszdravnadzor has already begun. The first document confirming the safety and approval of the devices for use in Russian hospitals is expected this year.