Logo 1zu1scale navy - Kunststoffbauteile - Schnell. Präzise. Skalierbar.

Mobile Menu

Precision for Heart Implants

Reduced Risk of Stroke with the Help of 3D Printing

Qatna Medical developed a novel system for closing the left atrial appendage to prevent strokes in patients with atrial fibrillation. 1zu1scale created a compact, sterilizable handle for the implant delivery system from six additively manufactured plastic components—a technical milestone in medical technology.

Small and precise plastic components with series character are our specialty. We manufacture them for medical technology using 3D printing and injection molding in clean room quality. Pioneering projects such as the one with Qatna Medical demonstrate what is possible today.

Stefan Rädler,Division Manager Additive Manufacturing

Innovative Solution for Safe Procedures

The 3D-printed handle is a key component of the implant delivery system for minimally invasive closure of the left atrial appendage. It enables medical staff to handle the device intuitively and safely during the procedure. The six components are sterile, leak-proof, and easy to clean—crucial factors in a medical environment. Additive manufacturing made it possible to realize complex geometric requirements such as internal threads and underlying channels without expensive tools or complicated assembly. This handle contributes significantly to supporting the vision of improved, low-drug therapy for stroke risk.

view_in_ar
Components

Six additively manufactured components form the handle of the insertion system.

folder_info
Properties

EN ISO 13485 certified

linear_scale
Scaling

2,000 copies for validation tests

add_box
Additional Services

SLS technology with chemical smoothing and printing

SCALE: One Process, many Advantages

Sketch

The idea becomes a solution

  • Clear definition of requirements right from the start
  • Focus on function, biocompatibility, and sterilizability
  • Solid foundation for marketable medical technology

Check

Trust through validation

  • Iterative testing with 3D-printed prototypes
  • Realistic test runs and regulatory coordination
  • Step-by-step validation until product maturity

Approve

Validated. Approved. Finalized.

  • Fully validated product design
  • Formal approval for the market
  • Design freeze as a guarantee for regulatory compliance

Launch

Ready for the market

  • Structured market launch
  • Development of a flexible, additive production strategy
  • Ready for series production – scalable, reliable, deliverable

Execute

Scaling without compromise

  • Series production without product changes
  • Flexible market rollout thanks to 3D printing
  • Cost-effective manufacturing of complex medical technology – on demand and in series

A Result that is impressive

1zu1scale created a sterilizable handle for Qatna Medical from six 3D-printed components with complex geometries. Additive manufacturing enabled rapid iterations, high geometric freedom, and compliance with medical technology standards. The result: a functional, production-ready component that supports minimally invasive procedures and makes innovative therapy safe for patients.

1zu1scale thinks along with us. Good suggestions, honest, open communication, and face-to-face meetings make it easier for us to implement our ideas and designs. As a developer, this service was a new experience for me. This is exactly how I imagine a solution-oriented manufacturing partner to be.

Felix Schneider,Development Engineer at Qatna Medical GmbH

Questions & Answers

It serves as part of the implant insertion system for minimally invasive closure of the left atrial appendage.

Six chemically smoothed and partially printed components.

Selective laser sintering (SLS) with chemical smoothing and optional coloring for high precision and surface quality.

Sterilizability, biocompatibility, high-quality surfaces, and certifications such as EN ISO 13485.

With certified processes and experience in the realization of regulation-relevant components.

After verification and validation tests, clinical trials and the approval process are planned.

Project Managers

From idea to series: The people behind the project.

1zu1direkt
arrow_outward