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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) with malperfusion.

AMDS-Perfusion

Product Highlights

  • Reduction in Major Adverse Events (MAE’s)1-7

  • Prevention of DANE6-9

  • Resolution of Malperfusion9

  • Promotes Positive Aortic Remodeling6-8

  • Ease of Use6

Product Overview

Design Features Delivery System
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1. PTFE FELT CUFF

AMDS4

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

AMDS5

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

AMDS6

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

AMDS8

When deployed in vessel, the distal ends of the stent are designed to point away from the aortic wall to avoid Distal Stent Graft-Induced New Entrys (dSINE).7,8

AMDS3
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1. RED CAP

Not functional.

AMDS DS1

2. GUIDEWIRE (GW) EXIT

Compatible with 0.035” GW (optional).

AMDS DS2

3. HANDLE

Ergonomic handle for easy grip during delivery.

AMDS DS2

4. GREEN CAP

To deploy/release the suture constraining the stent.

AMDS DS1

5. PROTECTIVE SHEATH

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

AMDS DS3

6. LOADED STENT

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

AMDS DS5

7. PIGTAIL SHAPED TIP

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

AMDS DS4

AMDS9

“Knowing that you’re giving people surgery that is not having any additional complexity but with a better outcome is very reassuring.”

Dr. Michael Moon, Canada

“A new tool in the toolbox for surgeons to do a better operation at the time of an index operation for a DeBakey I.”

Dr. Wilson Szeto, United States

Clinical Evidence

PERSEVERE US IDE Study Early and Midterm Results:
A Landmark Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of AMDS™ in the Treatment of Acute DeBakey Type I Dissection (ADTI) with Malpersusion.

 

Key 30-day PERSEVERE US IDE Results

 

 

Average AMDS implant time* = 15 minutes6

 

*Implant time includes time from AMDS delivery system insertion to the completion of the AMDS anastomosis to the native aorta

 

 

 

 

 

 

 

 

Key 1-year PERSEVERE US IDE RESULTS

 

 

AMDS promotes positive aortic remodeling by maintaining a stable total aortic diameter while sustaining the true lumen and continuing to thrombose the false lumen.7

 

Product Animation

The animation below demonstrates AMDS implantation.

Additional Resources

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

PERSEVERE US IDE EARLY AND MIDTERM RESULTS

Download PDF

AMDS QUICK REFERENCE GUIDE

Download PDF

AMDS CLINICAL BROCHURE

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  1. Zindovic I, G. T., Ahlsson A, Fuglsang S, Gunn J, Hansson EC, Hjortdal V, Jarvela K, Jeppsson A, et al. . (2019). Malperfusion in acute type A aortic dissection: an update from the Nordic Consortium for Acute Type A Aortic Dissection. J Thorac Cardiovasc Surg.,157, 1324-1333.
  2.  Pacini D, L. A., Belotti LM, Fortuna D, Gabbieri D, Zussa C, Contini A, Di Bartolomeo R, et al. (2013). Acute type A aortic dissection: significance of multiorgan malperfusion. Eur J Cardiothorac Surg, 43, 820-826.
  3. Geirsson A, S. W., Pochettino A, McGarvey ML, Keane MG, Woo YJ, Augoustides JG, Bavaria JE. (2007). Significance of malperfusion syndromes prior to contemporary surgical repair for acute type A dissection: outcomes and need for additional revascularizations. Eur J Cardiothorac Su, 32, 255-262.
  4. Girdauskas E, K. T., Borger MA, Falk V, Mohr FW. (2009). Surgical risk of preoperative malperfusion in acute type A aortic dissection. J Thorac Cardiovasc Surg, 138, 1363-1369.
  5. Bossone E, R. V., Nienaber CA, Trimarchi S, Ballotta A, Cooper JV, Smith DE, Eagle KA, Mehta RH. (2002). Usefulness of Pulse Deficit to Predict In-Hospital Complications and Mortality in Patients With Acute Type A Aortic Dissection. Am J Cardiol, 89, 851-855.
  6. 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.
  7. Adjudicated data as presented at the 61st STS Annual Meeting by Dr. S. Fukuhara on behalf of corresponding authors, One-Year Results of a Novel Aortic Arch Hybrid Prosthesis for Open Repair of Acute DeBakey Type I Dissection with Malperfusion in the PERSEVERE Study / Friday, January 24, 2025 / 10:00 am – 10:15 am.
  8. Bozso SJ, N. J., Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Forcillo J, Kempfert J, Stark C, Moon MC. (2022). 3-Year Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. J Thorac Cardiovasc Surg.
  9. Bozso, Sabin J. et al. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. The Annals of Thoracic Surgery, Volume 108, Issue 6, 1768 – 1775. DOI: https://doi.org/10.1016/j.athoracsur.2019.04.121

CAUTION: 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. MWENG0019.002. (2025-09).

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