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AMDS SIZING SHEET

AMDS SIZING SHEET
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AMDS SIZING SHEET

Product catalog summary
Document Overview: This document is a sizing sheet for an investigational medical device, specifically related to aortic measurements for potential implantation. It includes sections for patient and assessment details, device specifications, and measurement guidelines.
Patient and Assessment Details: The document provides fields to record the date of assessment, evaluator's information, hospital/city/country, CT/MRI details, patient initials, date of birth, gender, and implantation date.
Device Caution: The device is investigational and limited by law to investigational use in the United States. Not all products and indications are available or approved in all markets. Users are advised to refer to the Instructions for Use for detailed information on indications, contraindications, precautions, and potential adverse events.
Company Information: The document is issued by Artivion, Inc., with contact details provided for both the USA and Germany. Artivion, Inc. owns all trademarks, and Ascyrus Medical GmbH is a subsidiary.
Measurement Specifications: The document outlines specific aortic diameter measurements required for device sizing:
  • D1: Maximum aortic diameter between the Brachiocephalic Trunk and the Left Common Carotid Artery.
  • D2: Maximum aortic diameter at the level of bifurcation of the pulmonary artery.
Device Reference: The document provides a reference table for AMDS (Aortic Measurement Device System) with corresponding diameter ranges:
  • AMDS4030: D1 20-35 mm, D2 20-24 mm
  • AMDS4040: D1 20-35 mm, D2 25-35 mm
  • AMDS5540: D1 36-45 mm, D2 27-35 mm
  • AMDS5555: D1 36-45 mm, D2 36-45 mm
Measurement Examples: The document includes examples for measuring D1 and D2 using pre-operative CT scans, specifying the measurement from adventitia to adventitia.
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Catalog excerpts

AMDS SIZING SHEET-1

Sizing Sheet Patient initials Implantation date Date CT/MRI/Slice thick. At the level between the innominate and left common carotid artery At the level of the bifurcation of the pulmonary artery Using pre-op CT scan, measure the aortic vessel diameter (adventitia to adventitia): D1 Maximum aortic diameter between the Brachiocephalic Trunk (Innominate) and the Left Common Carotid Artery D2 Maximum aortic diameter at the level of bifurcation of the pulmonary artery AMDS reference Learn more at artivion.com CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use. All products and indications are not available/approved in all markets. Refer to the Instructions for Use for indications, contraindications, precautions, and potential adverse events. All trademarks are owned by Artivion, Inc. or its subsidiaries, Ascyrus Medical GmbH is a wholly owned subsidiary of Artivion, Inc. © 2023 Artivion, Inc. All rights reserved. Artivion, Inc., 1655 Roberts Blvd., NW, Kennesaw, GA 30144 USA Phone: +1-888-427-9654 | Fax: +770-590-3753 | E-mail: [email protected] For contact information by region, please visit. www.artivion.com/contact Ascyrus Medical GmbH, Grosse Gallusstrasse 16-18, 60312 Frankfurt, Germany MLENG1639.000 (2023-11)

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