Additive Intervertebral Implants of the FIEP RUSNANO Start-Up Began to Be Used in Large Russian Clinics

15 May 2020

For the first time, individual additive cages from Pozvonoq, a joint project of the North-West Center for Technology Transfer (NWCTT) and the Ortoinvest production company, have been installed in large Russian clinics to patients with spinal diseases. The NWCTT is part of the investment network of the RUSNANO’s Fund for Infrastructure and Educational Programs (FIEP).  The use of the Pozvonoq 3D printed cages has become an alternative to non-dynamic spine stabilization by splicing the lumbar vertebrae (OLIF, ALIF, and TLIF). The company is ready to replace half of the imported cages currently used in surgeries in Russia.

 Pozvonoq customized additive cages

Pozvonoq customized additive cages

The intervertebral cages (interbody implants) are widely used in the surgical treatment of patients with complicated degenerative spine pathology (osteochondrosis) in the form of spondyloarthrosis, spinal stenosis, and instability of the spine segments when the removal of deformed intervertebral discs is required. Traditional technologies involve the use of bone and polymer cages with a limited range of sizes; therefore, 3D printed cages, which can be almost perfectly picked up, thereby improving the quality of life of the patient, are increasingly spreading. The purpose of the cage is to stabilize the spine after decompression (release of nerve structures) due to spondylodesis, i.e., the fusion of the vertebrae. During surgery, the damaged intervertebral disc is replaced by a hard cage with bone tissue, which holds one vertebra above the other at the proper distance, thereby fixing the damaged spine segment. Over time, the vertebrae grow together through the cage holes into a single bone block. On the second day after the surgery, the patient can get up and is discharged home in less than a week. Correct installation and adherence to the correct motor regimen by the patient contribute to the absence of the need to replace the cages throughout life.

Currently, Russia performs about 10,000 surgeries per year using traditional foreign-made intervertebral cages, and Pozvonoq is ready to replace up to half of this need with its products. “In 2021, 450 types of our serial products will enter the market and will be commercially available in any clinic. The presented assortment covers the entire range of products for infertile spondylodesis and relevant surgical techniques,” said Olga Voblaya, Director of Pozvonoq.

 Pozvonoq customized additive cages

Pozvonoq customized additive cages

The 3D printed intervertebral cages have been installed in patients in the U.S., Great Britain, and Germany since 2017, and by the beginning of 2020 more than 20,000 similar surgeries have been performed. The 3D printed endoprostheses are also widely used for bone and joint reconstruction after severe trauma and cancer.

The development of Russian additive cages began in early 2018: based on the world experience, the optimal geometry and structure of implants were chosen. Each cage is modeled by a special algorithm taking into account the individual anatomy and the nature of the patient’s pathology. Medical additive devices are made from a fully biocompatible certified titanium alloy. The 3D printing technology allows for the creation of a mesh structure to better integrate a titanium implant with the patient’s bone tissue.

The experts of the R.R. Vreden Russian Research Institute of Traumatology and Orthopaedics in St. Petersburg were among the first to use the Russian additive cages. In addition, the Institute has a number of its patents in this area. Dmitry Ptashnikov, President of the Russian Association of Vertebrologists, Scientific Director, Head of the Department of Spinal Pathology and Bone Oncology at the R.R. Vreden Russian Research Institute of Traumatology and Orthopaedics, Deputy Head of Traumatology, Orthopedics, and Military Field Surgery at the North-Western State Medical University named after I.I. Mechnikov, Ph.D., Professor, sees great prospects for improving additive technologies and is confident in expanding the scope of their use in surgery. “This technology is a modern domestic promising development. Now, it shows excellent results, allowing to adapt implants to the anatomical features of a particular patient and to achieve the required orthopaedic and clinical results with a minimum number of fixed segments. They have proven themselves in the treatment of the entire spectrum of pathological conditions in vertebrology—from trauma and degenerative diseases to spine tumors. Further studies on the change in the porosity and plasticity of the material will contribute to their early implantation and reduction of the frequency of pseudo-arthrosis,” said Professor Dmitry Ptashnikov.

At the Privolzhsky Research Medical University (PRMU) in Nizhny Novgorod, surgeries using new cages are regularly performed. Andrey Bokov, the PRMU researcher, Ph.D., noted: “The Pozvonoq cage wins the competition from other manufacturers through geometry, which greatly facilitates the installation of front access even for patients with a body mass index of more than 36. The size range also includes hyperlordotic cages, which allow front-access correction of degenerative deformations, representing an innovative global trend. The supply of customized cages taking into account the features of the spine structure in a particular patient is also possible. It should be noted that these implants are delivered quickly. The cages are produced in Russia, which will make them less dependent on currency fluctuations. The implants developed are competitive with analogues of foreign and domestic manufacturers both due to quality and also due to their lower cost as compared to that of the most well-known manufacturers.”

The need to use additive technologies in spinal surgery is also noted by specialists of the Russian Ilizarov Scientific Center for Restorative Traumatology and Orthopaedics, where, since 2018, a major study has been carried out on the effectiveness and safety of using the 3D printed interbody implants to stabilize the vertebrae and pelvic joints, as well as in the large bone defects replacement. 

“The main advantages of the additive cages are the ability to manufacture and apply them taking into account the nature of pathology, individual anatomy, and bone parameters of a particular patient. The critical production aspects should be a well-established pre-surgery planning protocol and a short production cycle from the 3D digital model to the finished individual product. The medical advantages also include the high quality of the product, safety, and good preliminary biocompatibility. In addition, the low cost of the product determines the good marketing prospects of these implants and allows to hope for the greater use of technologies with proven efficiency in our country,” Deputy Director of Education and Interaction with the Regions, Head of the Clinic of Spinal Pathology and Rare Diseases of the Russian Ilizarov Scientific Center for Restorative Traumatology and Orthopaedics, PhD, Sergey Ryabykh is sure. 

The Pozvonoq start-up of the Northwest Technology Transfer Center and the Ortoinvest Russian production company, developing and producing power equipment and implants for traumatology and orthopedics, plans to start production of serial 3D printed cages in 2020. The engineering is carried out by CML AT Medical, 3D printing—by TEN MedPrint, from the TEN Group of the TechnoSpark Group of Companies. The distributor is Altermedika, one of the leaders in the distribution of implants and endoprostheses in Russia.

Reference

The Fund for Infrastructure and Educational Programs was established in 2010 in accordance with Federal Law No. 211-FZ “On reorganization of the Russian Corporation of Nanotechnologies.” The Fund aims to develop the innovative infrastructure in the sphere of nanotechnology and implement the educational and infrastructure programs already started by RUSNANO.

The supreme collegial management body of the Fund is the Supervisory Board. Under the Fund’s Charter, the competence of the Supervisory Council, in particular, includes the issues of determining the priority directions of the Fund’s activity, as well as its strategy and budget. The Chairman of the Fund’s Executive Board, the collegial management body, is the Chairman of the Board of Management Company RUSNANO LLC Anatoly Chubais; the Chief Executive Officer of the Fund is Andrey Svinarenko.