11:21 AM EST, 12/09/2024 (MT Newswires) -- Artivion ( AORT ) said Monday it has received a humanitarian device exemption from the US Food and Drug Administration, allowing the commercial distribution of its AMDS hybrid prosthesis device to treat acute DeBakey Type 1 aortic dissections.

Under HDE, the AMDS hybrid prosthesis will be available as a treatment for acute DeBakey Type 1 dissections in the presence of malperfusion, Artivion ( AORT ) said. If its premarket approval application for the device is approved, the device may be used in all DeBakey Type 1 dissections, including those without malperfusion, the company added.

Artivion ( AORT ) said the HDE helps position AMDS hybrid prosthesis for a broader commercial launch, letting the company obtain approvals from institutional review boards and hospital value analysis committees and starting the process of training surgeons to implant the device.

Artivion ( AORT ) shares were down more than 3% in recent trading.

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