FDA approves surgical device for high-risk aortic procedures

Michael Walter | June 29, 2026 | Cardiovascular Business | Vascular & Endovascular

Artivion, an Atlanta-based medical device company, has received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis designed to treat DeBakey Type 1 dissections when malperfusion occurs. This HDE ensures select patients can be treated with the device before the FDA makes its final approval decision.

Image courtesy of Artivion.

Artivion, an Atlanta-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for its AMDS Hybrid Prosthesis.

The AMDS was designed to help clinicians treat DeBakey Type 1 dissections complicated by malperfusion. It works as a complement to hemiarch replacement, preserving the native arch and making reinterventions possible if needed. According to Artivion, it is the first surgical device of its kind.

In December 2024, the AMDS received the FDA’s Humanitarian Device Exemption (HDE). This allowed select patients to undergo treatment with the device, but a separate institutional review board (IRB) approval was still required in each instance. Thanks to this full approval, the AMDS is now covered across the board for the treatment of all DeBakey Type 1 dissections with clinical or radiographic malperfusion.

The FDA’s decision was largely based on data from PERSEVERE, a clinical trial exploring the safety and effectiveness of hemiarch replacement with the AMDS device in 93 patients. Overall, after 30 days, the Artivion device was associated with a 72% reduction in all-cause mortality and a 54% reduction in major adverse events. A two-year follow-up study presented in February 2026 confirmed that the benefits of treatment persisted well after that initial 30-day window.

“We are thrilled to receive AMDS premarket approval, as it not only validates the enduring benefits shown in the PERSEVERE clinical data but also removes a barrier to broader adoption by eliminating the IRB requirement that came with the HDE,” Pat Mackin, chairman, president and CEO of Artivion, said in a statement. “Having already built commercial and clinical infrastructure during our HDE launch, and with strong reordering momentum among accounts already using AMDS, we expect this premarket approval to help accelerate adoption of this life saving technology.”