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.
From idea to medical concept
Qatna Medical wanted to develop a novel insertion system for a cardiac implant that is minimally invasive, ergonomic, and intuitive to use. The focus was on a sterilizable handle consisting of several components, which requires high precision and must also be suitable for clinical testing and series production.
Complexity meets medical technology
The project placed the highest demands on design, materials, and manufacturing: undercuts, threads, and narrow channels had to be implemented with precision, while the handle had to remain sterilizable and reproducible. At the same time, close coordination between Qatna Medical and 1zu1scale was necessary to comply with regulatory requirements and ensure ergonomic functionality.
Combining functionality and readiness for series production
The goal was to develop a functional, regulatory-compliant handle that was ready for series production and met all geometric, ergonomic, and sterilization requirements. The handle was designed to enable safe handling of the cardiac implant during minimally invasive procedures and lay the foundation for future series production.
Start
From idea to medical concept
Qatna Medical wanted to develop a novel insertion system for a cardiac implant that is minimally invasive, ergonomic, and intuitive to use. The focus was on a sterilizable handle consisting of several components, which requires high precision and must also be suitable for clinical testing and series production.
Challenges
Complexity meets medical technology
The project placed the highest demands on design, materials, and manufacturing: undercuts, threads, and narrow channels had to be implemented with precision, while the handle had to remain sterilizable and reproducible. At the same time, close coordination between Qatna Medical and 1zu1scale was necessary to comply with regulatory requirements and ensure ergonomic functionality.
Goal
Combining functionality and readiness for series production
The goal was to develop a functional, regulatory-compliant handle that was ready for series production and met all geometric, ergonomic, and sterilization requirements. The handle was designed to enable safe handling of the cardiac implant during minimally invasive procedures and lay the foundation for future series production.
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.
Assembly
Six additively manufactured components form the handle of the insertion system.
EN ISO 13485 certified
Production process meets medical technology standards
approx. 2,000
Planned copies for verification and validation tests
SLS technology with chemical smoothing and optional dyeing
Stable, smooth, sterilizable components with complex geometries
Assembly
Six additively manufactured components form the handle of the insertion system.
EN ISO 13485 certified
Production process meets medical technology standards
approx. 2,000
Planned copies for verification and validation tests
SLS technology with chemical smoothing and optional dyeing
Stable, smooth, sterilizable components with complex geometries
One process, many advantages
The project follows a structured development process that covers all steps from the initial idea to series production:
- Concept development and definition of functional requirements, biocompatibility, and sterilizability.
- Iterative validation with 3D-printed prototypes, test runs, and alignment with regulatory standards.
- Approval and optimization of the final design for additive manufacturing.
- Series production of sterilizable, precise, and reproducible components.
This enables the creation of a component that is regulatory compliant, reflects geometric complexity, and can be manufactured economically—a prime example of innovative medical technology product development.
An impressive result
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 delivery 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 implementation of regulatory-relevant components.
Following verification and validation tests, clinical trials and the approval process are planned.
Project Manager
From idea to series: The people behind the project.
