Qatna develops, manufactures, and markets medical devices with the highest quality standards – “Made in Germany.”
The company invests in the latest technologies and specializes in minimally invasive applications. These are made possible in part by additively manufactured plastic components from 1zu1 in Dornbirn (part of Prototal Group). They mark a real milestone for 3D printing and medical technology: Sterilizable, production-ready, and regulatory-compliant components are now feasible.
The medical device closes the left atrial appendage – an evolutionary remnant. This protects people with atrial fibrillation from blood clots that can lead to strokes. At the same time, the risk of bleeding is reduced by eliminating the need for blood thinners. After the minimally invasive surgery and safe placement of the Qatna Medical implant, affected individuals need less medication for their heart and gain quality of life. That is the vision. It is set to become reality in 2028 once the clinical trials have been completed.
This is also made possible by plastic parts from a 3D printer. 1zu1 from Dornbirn has created a compact handle for the implant insertion system, exploiting the full potential of selective laser sintering. Six chemically smoothed and partially printed components fit together perfectly, are leak-proof and easy to clean. With medical device-specific certification according to EN ISO 13485, 1zu1 also facilitates the complex approval process. With the final design of the insertion system, verification and validation will now follow. Approximately 2,000 copies will be needed for testing in the coming months. It’s a good thing that 1zu1 can easily deliver large quantities, whilst keeping quality, with the P500 SLS system from EOS. Once the product is approved, demand will increase. But there is still some time until then.
Back to the beginning and off to Hechingen. The idyllic small town on the edge of the Swabian Alb is known for its Medical Valley. Numerous companies and start-ups develop innovative medical technology products here. Since its foundation in 2019, Qatna Medical has specialized entirely in the secure closure of the left atrial appendage. Unlike conventional implants, the novel method relies on natural tissue instead of synthetic material. This is intended to speed up the recovery phase.
He is responsible for the plastic parts of the insertion system. In addition to nine sterile injection-moulded parts – also produced by 1zu1 – this includes the six 3D-printed components mentioned above. Their additive manufacturing was planned from the outset. This was also due to Prototal’s sister company 1zu1‘s (part of Prototal Group) good reputation in Medical Valley.
With Qatna Medical’s needs in mind, he discussed the possibilities and limitations of the technology with 1zu1 innovation manager Markus Schrittwieser. Felix Schneider quickly realized how much time and money 3D printing can save – and how much flexibility it offers. So he got to work. Six parts are assembled and screwed together to form the compact handle. The implant is secured using an integrated locking mechanism. There is also a channel for rinsing before use in the operating room. The whole thing has to be sealed to create sufficient contact pressure for the catheter tube. “With such a complex geometry with internal threads, undercuts, and large differences in wall thickness, injection moulding tools would have been really expensive and assembly would have been complicated. 3D printing offers complete freedom in terms of design and functionality.”
Despite all its advantages, 3D printing is far from established as a serial production process for medical technology. Specialists such as 1zu1 want to change this – and they have good arguments for doing so. “In most cases, a lack of experience leads to reservations. When it comes to 3D printing, many people think of fragile prototypes or grainy, rough surfaces. We prove the opposite with stable, smooth, sterilizable, and repeatable components made of biocompatible polyamide,” emphasizes Stefan Rädler, Head of Additive Manufacturing at 1zu1. Qatna Medical also experienced the high technical maturity of the Dornbirn-based high-tech company, as Felix Schneider reveals: “Even the sample parts were so precise, stable, and attractive that internal concerns were quickly dispelled.”
Felix Schneider and the team at 1zu1 maintain close contact, including mutual visits. “We speak the same language, even in technical terms. This allows us to find solutions to minor problems more quickly and save valuable time,” says the engineer happily. At the beginning of 2025, the tool-free process allowed for a design revision and some fine adjustments. This would be almost unthinkable with conventional manufacturing processes. “We have now optimized all elements and created a tight grip. We were able to shorten the flow channel, making cleaning easier,” says Felix Schneider happily. Although the handle does not come into contact with blood and other fluids, Qatna Medical and 1zu1 adhere to the highest quality standards. “The goal is cleanroom quality. To achieve this, all components are cleaned and double-packaged by an external partner. ISO certification is an important building block for our success,” says Stefan Rädler.
