The medtech company Qatna Medical is preparing a clinical trial for an implant to occlude the left atrial appendage, designed to protect patients with atrial fibrillation from strokes. Key components of the delivery system are being manufactured by 1zu1 in Dornbirn, a specialist in additive manufacturing and cleanroom injection molding. The focus is on small, geometrically complex plastic components produced in short iteration cycles and suitable for sterile processing.
At the heart of the project is a compact handpiece made up of six parts produced by selective laser sintering (SLS). The parts are chemically smoothed to reduce porosity and surface roughness, which improves cleanability and stabilizes sealing surfaces.
Around 2,000 units are needed for validation and verification tests. Series production will take place on an EOS P 500 SLS system; the material used is a biocompatible polyamide that can be qualified for common sterilization processes.
1zu1 points to its EN ISO 13485 certification, in place since the summer, which structures regulatory procedures in design and change management.
“With such complex geometry featuring internal threads, undercuts, and large wall-thickness variations, injection-molding tools would have been very expensive and assembly complicated. 3D printing offers full freedom in design and functionality,” says Felix Schneider, development engineer at Qatna Medical.
The launch of the clinical study is expected to show whether the interplay between the implantable tissue and additively manufactured delivery components can pave the way for a minimally invasive therapy with reduced medication needs.
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