FIXTER

The aim of the project was the development of a costeffective, easy-to-use closure system in plastic, lightweight construction, which combines the advantages
of solutions available on the market for the healing process of the sternum after surgery by means of a rigid fixation.

The median sternotomy is a standard surgical procedure to access the cardiothoracic cavity, for example in open heart surgery. Therefore, a vertical incision must be made along the sternum. Once the operation is complete, the two halves of the sternum must be brought together again and securely fixed in place. This is the only way to ensure adequate bone healing and recovery of the patient. Existing solutions for stabilizing the sternum halves can be divided into two groups. On the one hand, there are rigid fixations which, due to their robust design, require complex application by the surgeon and thus higher costs. On the other hand, comparatively affordable wire solutions are used, which, for example, cannot be used for high-risk patients due to their poorer fixation. Therefore, the STERN FIX® closure system combines the advantages of existing, metallic solutions by a new technological development in plastic design. IVW focuses on the development and design of the closure system using finite element methods. The project partner NEOS takes care of the development of a manufacturing process for the production of first prototypes. At the same time, a test cell for biomechanical evaluation of the complete closure system will be set up by the project partner SpineServ.

• SpineServ GmbH & Co. KG

• Neos Surgery S.L.