---
title: "Artivion wins FDA approval for AMDS Hybrid Prosthesis in acute DeBakey Type I aortic dissection"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/291133288.md"
description: "Artivion received FDA PMA clearance for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion. This approval removes the previous IRB requirement associated with the HDE pathway, thereby expanding U.S. hospital access to the device. The company estimates the addressable U.S. market opportunity at $150 million annually."
datetime: "2026-06-29T11:01:10.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/291133288.md)
  - [en](https://longbridge.com/en/news/291133288.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/291133288.md)
---

# Artivion wins FDA approval for AMDS Hybrid Prosthesis in acute DeBakey Type I aortic dissection

-   Artivion won U.S. FDA PMA clearance for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion. \* The decision removes the prior IRB requirement tied to the HDE pathway, broadening U.S. hospital access to the device. \* Artivion pegged the addressable U.S. market opportunity at USD 150 million annually. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Artivion Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202606290700PR\_NEWS\_USPR\_\_\_\_\_CL93538) on June 29, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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