AMDS™ Hybrid Prosthesis Implantation Technique Transect the ascending aorta perpendicularly (not beveled): • Leave >10mm proximal to the native arch branch vessels • Leave adequate tissue on lesser curvature to allow for circle to circle anastomosis of AMDS to aorta Introduce device into the true lumen through the open distal aorta until the PTFE cuff is in the same plane as the transected aorta. Retract and remove the protective sheath to fully expose the PTFE felt. Quick Reference Pre-Op: Using CT Scan 1 Confirm Acute DeBakey I dissection with primary entry tear location in ascending aorta (Figure 1). Assess arch, descending, and supra-aortic vessels for additional re-entry tears to determine whether more extensive arch replacement indicated. Measure the aortic vessel diameter (adventitia to adventitia) at D1 and D2 anatomical landmarks as shown below. It is recommended to take measurements in axial view. At the level between the innominate and left common carotid artery Stabilize the AMDS felt to the aorta by placing 4 tacking sutures starting at lesser curve 6, followed by 12, 3, and 9 o’clock positions. Use of a PTFE felt strip external to the aorta is highly recommended to avoid excessive tension or tearing of the aorta. At the level of the tracheal bifurcation of the pulmonary artery Unscrew the green cap counterclockwise and pull back the cap and connecting ePTFE suture to deploy the stent. 45 mm Remove the delivery system, making sure the tip is free from the distal end of the stent. Create a sandwich type anastomosis securing the inner AMDS felt cuff through the aorta and to the outer PTFE felt. Ensure no folding of the inner felt occurs. Perform the conventional surgical graft to aorta-AMDS anastomosis. Ensure each suture bite incorporates the conventional graft and the felt-aorta-AMDS felt sandwich creating a meticulously tight seal between the layers. Note: It is important to avoid putting tension on the distal anastomosis. When completing the proximal anastomosis, leave the ascending graft long enough to avoid tension. Watch the Animation: www.artivion.com/product/AMDS Reference sizing chart below to select appropriate AMDS and do not oversize. When in between sizes, err on selecting the smaller size device. Device Specifications D1: Proximal Aortic Diameter D2: Distal Aortic Diameter Felt Diameter Stent Diameter (Free State) • All measurements in mm. • All devices compatible with .035 guide wire but not required for use. 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 MLENG1636