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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.

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.

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Components

Assembly of 16 components manufactured in a clean room

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Properties

Clean room manufacturing and EN ISO 13485 certified

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Scaling

Tested hundreds of times – now infinitely scalable.

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Additional Services

Printed with your own logo – precisely using pad printing.

SCALE: One Process, many Advantages

Sketch

Idea meets biocompatible design

  • Support for the project from the early prototype phase to series production readiness
  • First functional 3D printed parts made of biocompatible material enabled testing in preclinical studies
  • Goal: robust, clinically applicable design right from the start

Check

Precision through iterative validation

  • Close coordination between MEDIRA and 1zu1scale
  • Optimization of undercuts, injection points, and tolerances
  • Ensuring series production capability and functional reliability

Approve

Design finalized & approved

  • Tool approval after successful validation
  • Design freeze: no further changes to the product
  • Basis for fast, reproducible series production

Launch

Series production start prepared

  • Production of the first injection-molded parts just three months after tool approval
  • Integration of individual colors, printing, and clean room production
  • Preparation for series launch after clinical validation

Execute

Series production readiness implemented

  • Series production of clinically validated components
  • High precision and reproducible quality guaranteed
  • Product ready for immediate use for market launch

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.

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