CE Marking Awarded for STERN FIX® Closure System

Design of Composite Structures4Medical Engineering20News25

Open-heart surgery requires access to the cardiothoracic cavity. For this purpose, the surgeon separates the sternum longitudinally (sternotomy) and fixes the sternum halves after the surgery in a safe way. Since existing solutions for stabilizing the sternum halves can create deficits during implementation (laborious handling of metallic implants) and complications during healing (cutting into the bone when using wires), a novel, cost-effective, easy-to-handle composite implant that is better adapted to bone stiffness was developed in the EUREKA project FIXTER.

The STERN FIX® closure system developed by NEOS Surgery in collaboration with Leibniz-Institut für Verbundwerkstoffe GmbH and SpineServ, has now achieved CE marking, successfully demonstrating that the prescribed conformity assessment procedure has been carried out and that the medical device meets the General Safety and Performance Requirements.

For further information please visit https://www.ivw.uni-kl.de/en/projects/fixter

Stress distribution in the STERN FIX® closure system (core implant) under loading condition (widening of the thorax e.g. when coughing)


Nicole Motsch-Eichmann

Manager Design of Composite Structures

Special Expertise: Structural design and development of fiber composite structures, finite element analysis (static), development of load introduction regions, experimental testing of components and parts, topology and shape optimization

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