1月20日 的 Ankyras 應用程式分析

Ankyras makes the intracranial aneurysm treatment planning easier, accessible and more interactive. Intended use: Ankyras is a medical software intended to assist healthcare professionals in the selection of a proper braided stent device for the treatment of intracranial aneurysms. • Login for full access: Registered users can log in to access their case list and saved simulations. (Note: Medical images cannot be viewed on the mobile app.) • Access without login: Unregistered users can still open shared simulations without logging in. Shared cases can be accessed directly via a “View Case” email link. • Open shared simulations – You will receive an email when another user share a simulation with you. In the mail, click View case: Ankyras app will directly open the case. • Vessel morphology – Explore and quantify the vessel morphology to assess the fit of the desired braided device in the patients’ anatomy. • See, move and change FD devices – easily simulate the different devices and adjust their position if needed along the vessel. • Share simulations – Click the left corner menu button and share the simulation with others to facilitate case discussion. Ankyras includes both a free-registration version and a user-registration version with complete case processing features. You can get registered in www.ankyrasonline.com from a laptop or PC to get access to all simulation processing functionalities. The Ankyras support team will be in contact with you and facilitate the indications and instructions to start preparing your own simulations. Ankyras is a Medical Device manufactured by Mentice Spain S.L. and distributed by Mentice subsidiaries and partners in approved markets. Mentice Spain S.L. (SRN: ES-MF-000036826) is ISO 13485 certified with number MD 784027. Ankyras is CE marked under MDR (MDR 784032) and holds UKCA certification (UKCA 784033). It is 510(k) cleared by the FDA (K230006) and notified to ANVISA (registration number 81118630030). Ankyras v6.0-CE UDI-DI: 8437025622023. NB 2797 All operators must read the complete Instructions for Use before operating the ANKYRAS. The product should be used only by qualified and trained personnel. ANKYRAS is intended for exclusive use by professional users. The software is intended to assist healthcare professionals in the planning of endovascular treatment with flow diverters and cannot fully substitute their clinical judgement. The software should only be used in combination with equipment with the minimum system requirements listed. If the minimum system requirements are not met the system may not work as expected. For more information, please refer to the eIFU, available here: https://www.mentice.com/ankyras/ifu