Innovative Heart Valve Care
Stable System for artificial Heart Valves
MEDIRA is developing the TRICENTO⁽ᴳ²⁾ system, a novel method for treating heart valve defects without open heart surgery. 1zu1scale is manufacturing a high-precision insertion system with a total of 16 injection-molded components in a clean room, which will later be used in clinical trials.
Shared Vision for a new Therapy
MEDIRA, based in Balingen (founded in 2020), is working on TRICENTO⁽ᴳ²⁾ – a system for transfemoral venous insertion of artificial heart valves. The procedure requires an ergonomic and functional insertion system that meets the highest medical technology standards.
Large Components, tight Tolerances, complex Precision
The development required particularly large components such as a 44 cm long threaded rod, tight manufacturing tolerances, and complex geometries. At the same time, parts had to be manufactured to be ergonomic, reliable, and fully compatible—including coloring, printing, and cleanroom quality.
Production-ready Insertion Systems for Clinical Validation
The goal was to develop a high-quality, production-ready insertion system from functional prototypes that functions reliably, fits perfectly, and paves the way for clinical trials for market approval.
Start
Shared Vision for a new Therapy
MEDIRA, based in Balingen (founded in 2020), is working on TRICENTO⁽ᴳ²⁾ – a system for transfemoral venous insertion of artificial heart valves. The procedure requires an ergonomic and functional insertion system that meets the highest medical technology standards.
Challenges
Large Components, tight Tolerances, complex Precision
The development required particularly large components such as a 44 cm long threaded rod, tight manufacturing tolerances, and complex geometries. At the same time, parts had to be manufactured to be ergonomic, reliable, and fully compatible—including coloring, printing, and cleanroom quality.
Goal
Production-ready Insertion Systems for Clinical Validation
The goal was to develop a high-quality, production-ready insertion system from functional prototypes that functions reliably, fits perfectly, and paves the way for clinical trials for market approval.
We were able to leverage our strengths as a full-service provider and offer support in areas ranging from 3D printing, toolmaking, and injection molding to printing and CT measurement.
Lukas Dilsky,Project Manager Tooling & Injection Molding
Precise Components for safe Heart Valve Implantation
The delivery system for the TRICENTO⁽ᴳ²⁾ heart valve enables cardiologists to safely guide an implant through the vena cava and place it precisely. The system consists of 16 high-precision plastic parts, manufactured in a clean room, which fit ergonomically in the hand, fit together perfectly, and can be reproduced in large quantities. Thanks to these components, functional tests and validation processes can be carried out early in the development cycle, which speeds up approval.
Components
Assembly of 16 components manufactured in a clean room
Properties
Clean room manufacturing and EN ISO 13485 certified
Scaling
Tested hundreds of times – now infinitely scalable.
Additional Services
Printed with your own logo – precisely using pad printing.
Components
Assembly of 16 components manufactured in a clean room
Properties
Clean room manufacturing and EN ISO 13485 certified
Scaling
Tested hundreds of times – now infinitely scalable.
Additional Services
Printed with your own logo – precisely using pad printing.
One Process, many Advantages
This project also followed a clearly structured development process:
- Early prototype phase: Functional 3D-printed parts made from biocompatible material enabled early testing, e.g., in preclinical studies.
- Optimization: Intensive collaboration between MEDIRA and 1zu1 led to precise adjustments of undercuts, injection points, and tolerances.
- Injection molding implementation: The first injection-molded parts were ready just three months after tool approval.
- Clean room production: Parts ready for series production are manufactured, colored, and printed in a clean room—ready for clinical validation.
A Result that is impressive
1zu1scale created a complete insertion system for MEDIRA consisting of 16 high-precision plastic components in a clean room. The assembly has been ready for series production since summer 2023 and is now being used for validation and approval processes. The use of 3D-printed prototypes, close cooperation, and precise injection molding significantly reduced the development time.
Three months for injection-molded parts ready for series production in a clean room: such speed combined with the highest quality is unique. 1zu1scale has always been and continues to be reliable.
Korbinian Biehler,Senior Development Engineer at MEDIRA
Questions & Answers
It is used to position a heart valve implant via the vena cava.
A total of 16 precision plastic parts make up the system.
3D-printed prototypes and clean room injection molding with post-processing by printing.
The large threaded rod (44 cm) and tight tolerances for many complex components.
Since summer 2023, 1zu1 has been manufacturing the assembly in small series.
The first injection molded parts were ready just three months after tool approval.
Project Managers
From idea to series: The people behind the project.
