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    <description>The document reports a prospectively registered, multicenter randomized non-inferiority trial of PANVIS-A conducted under Good Clinical Practice. Results show non-inferior clinical and technical performance compared with manual procedures, comparable patient radiation and contrast exposure, and a substantial reduction in primary-operator radiation. The device had obtained national market authorization prior to publication, and the report frames ongoing iterative development and first-in-human work for successor systems within the regulatory lifecycle.</description>
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