Artivion’s AMDS Hybrid Prosthesis Awarded FDA Humanitarian Device Exemption

Artivion, a cardiac and vascular surgery company focused on aortic disease, has been granted Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for using its AMDS Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion.

The AMDS is the world’s first aortic arch remodeling device intended for use to treat acute DeBakey Type I aortic dissections.

An HDE is a marketing application for a product designated a Humanitarian Use Device (HUD). AMDS received both HUD and Breakthrough Designation because of its intended benefit for patients to treat or diagnose a rare disease or condition in which no other comparable options currently exist. The HDE allows for commercial distribution of AMDS in the U.S. before anticipated approval of a premarket approval (PMA) application.

Under this HDE, AMDS will be available as a treatment for acute DeBakey Type I dissections in the presence of malperfusion, which make up about 40% of all acute DeBakey Type I dissections in the U.S. The PMA, if approved, is anticipated to cover all acute DeBakey Type I dissections with and without malperfusion.

Today the standard of care is an ascending replacement or hemiarch repair. This procedure can successfully remove the primary entry tear but it fails to adequately address the remainder of the diseased aorta, causing complications in both the acute and long-term phases.

The AMDS is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity. The AMDS’ design allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, with deployment adding minimal time to the procedure. The AMDS’ deployment preserves the native arch, allowing for minimally invasive re-interventions if needed, rather than an invasive arch repair.

“This HDE from the FDA validates the groundbreaking nature of AMDS, a device with no comparable clinical alternative,” said Pat Mackin, chairman, president, and CEO of Artivion. “We will now work diligently with facilities and physicians in the U.S. to expand access to this life saving device as we continue to work towards PMA approval, which we still expect in late 2025. We thank every PERSEVERE investigator and study participant for helping to advance this revolutionary technology.”

Results from the PERSEVERE U.S. IDE trial

The trial consisted of 93 participants in the U.S. and met its primary endpoints demonstrating significant reduction of major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction at 30-days following AMDS implantation.

More specifically, data showed, from the use of AMDS, a 72 % reduction in all-cause mortality and a 54% reduction in primary MAEs, with zero occurrence of distal anastomotic new entry (DANE), when compared to the current standard of care hemiarch procedure.