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 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 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 shares were down more than 3% in recent trading.
Price: 28.73, Change: -0.93, Percent Change: -3.15
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