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AMDS

HYBRID PROSTHESIS

Elevate the Standard.

The world’s first device designed specifically to address the unique challenges of acute type A aortic dissection, specifically DeBakey Type I (ADTI)

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Product Highlights

  • Reduction in Major Adverse Events (MAE’s)5

  • Prevention of DANE1,2,5

  • Resolution of Malperfusion1, 2

  • Promotes Positive Aortic Remodeling 1

  • Ease of Use1,2,4,5

Product Overview

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1. PTFE FELT CUFF

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Component made of a PTFE felt tube is used to buttress and strengthen the aortic tissue in preparation to perform the conventional polyester graft to aorta anastomosis.

2. UNCOVERED NITINOL WIRE BRAIDED STENT

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Expands and supports the true lumen across the aortic arch and descending aorta thereby stabilizing the aortic wall and promoting remodeling.

3. STENT SUPPORTED CUFF

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The stent supported cuff of the AMDS and expansion of the AMDS from the arch distally, elevates and supports the intimal flap, reducing the tension on the suture line, avoiding the formation of DANEs in the friable anastomosis.

4. DESIGNED TO AVOID dSINE

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When deployed in vessel, the distal ends of the stent are designed to point away from the aortic wall to avoid dSINEs.

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1. RED CAP

Not functional.

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2. GUIDEWIRE (GW) EXIT

Compatible with 0.035” GW (optional).

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3. HANDLE

Ergonomic handle for easy grip during delivery.

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4. GREEN CAP

To deploy/release the suture constraining the stent.

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5. PROTECTIVE SHEATH

For simple and atraumatic introduction to the transected aorta (6 cm long).

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6. LOADED STENT

Flexible catheter shaft for simple tracking of system and atraumatic to vessel.

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7. PIGTAIL SHAPED TIP

Pigtail tip reduces risk of device tracking into FL via a entry tear/fenestration.

AMDS DS4

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Clinical Evidence

Proven Clinical Results

  • The 30-day data demonstrates that the use of AMDS significantly reduces 30-day MAEs, including mortality, in the surgical treatment of ADTI patients complicated by malperfusion.5
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True Lumen Expansion

  • DARTS study demonstrated sustained true lumen expansion ≥ 5.0 mm in aortic Zones 1-4 from pre-op to 3 years, post-op. 3
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False Lumen Reduction

  • DARTS study demonstrated complete or partial false lumen thrombosis in the majority of patients in Zones 0-4 at 3 years post-op.3
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Total Aortic Diameter Stabilization

  • DARTS study demonstrated total aortic diameter stability or decrease in a majority of patients in Zones 0-2 and half of the patients in Zones 3 and 4 at 3 years, post-op.3

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Product Animation

Additional Resources

Explore additional resources for AMDS below. For further information or to contact a sales associate in your area, contact us.

AMDS CLINICAL BROCHURE

AMDS QUICK REFERENCE GUIDE

PERSEVERE US IDE STUDY 30-DAY RESULTS

  1. Bozso, Sabin J., et al. “Three-year outcomes of the dissected aorta repair through stent implantation trial.” The Journal of Thoracic and Cardiovascular Surgery (2022).
  2. Bozso, Sabin J., et al. “Midterm outcomes of the dissected aorta repair through stent implantation trial.” The Annals of Thoracic Surgery 111.2 (2021): 463-470.
  3. DARTS Internal Data On File.
  4. Montagner, Matteo, et al. “The arch remodelling stent for DeBakey I acute aortic dissection: experience with 100 implantations.” European Journal of Cardio-Thoracic Surgery 62.2 (2022): ezac384.
  5.  Szeto WY, Fukuhara S, Fleischman F, Sultan I, Brinkman W, Arnaoutakis G, Takayama H, Eudailey K, Brinster D, Jassar A, DeRose J, Brown C, Farrington W, Moon MC. A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the PERSEVERE trial. J Thorac Cardiovasc Surg. 2024 Aug
    6:S0022-5223(24)00677-9.
  6. Zindovic I, 2019. Pacini D, 2013. Girdauskas E, 2009. Geirsson A, 2007. and Bossone E, 2002
CAUTION: Investigational Device. Limited by Federal (or United States) law to invetigational use. All products and indications are not available/approved in all markets. Refer to the device’s Instructions for Use for indications, contraindications, warnings, precautions, and possible complications. All trademarks are owned by Artivion, Inc. or its subsidiaries. On-X Life Technologies, Inc. Jotec GmbH and Ascyrus Medical GmbH are wholly owned subsidiaries of Artivion, Inc. © 2024 Artivion, Inc. All rights reserved. MWENG0041.000. (2024-09).
Ascyrus Medical GmbH, Grosse Gallusstrasse, 60312 Frankfurt, Germany