Artivion, Inc. (NYSE: AORT) has announced that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for its AMDS Hybrid Prosthesis (AMDS) for use in acute DeBakey Type I aortic dissections in the presence of malperfusion. This exemption allows for the commercial distribution of the device in the U.S. prior to anticipated Premarket Approval (PMA). The AMDS is the world's first aortic arch remodeling device designed for treating this life-threatening condition.
The HDE was granted based on data from the PERSEVERE US IDE trial, which demonstrated a significant reduction in major adverse events (MAEs) with the AMDS device compared to traditional treatments. Specifically, the trial reported a 72% reduction in all-cause mortality and a 54% reduction in primary MAEs at 30 days post-implantation. Notably, there were zero occurrences of distal anastomotic new entry (DANE) in AMDS-treated patients, compared to a 45% rate observed with the hemiarch procedure, the current standard of care.
Clinical Trial Data and Outcomes
The PERSEVERE trial, a prospective, multicenter, non-randomized clinical trial, included 93 participants in the U.S. who experienced acute DeBakey Type I aortic dissection. The trial met its primary endpoints, showing significant reductions in major adverse events (MAEs), including all-cause mortality, stroke, renal failure requiring dialysis, and myocardial infarction at 30 days following AMDS implantation. Key outcomes from the trial include:
- All-cause mortality: 9.7% (vs. 34.6% historical reference)
- New disabling stroke: 10.8% (vs. 20.9%)
- New onset renal failure requiring dialysis: 19.4% (vs. 24.1%)
- Myocardial infarction: 0.0% (vs. 10.5%)
- Distal anastomotic new entry (DANE): 0.0% (vs. 45%)
Expert Commentary
"The fact that the FDA has recognized the AMDS device through the HDE pathway is very encouraging and speaks to the unique aspects of the device to treat a rare and emergent condition," said Dr. Wilson Szeto, chief of cardiovascular surgery at the University of Pennsylvania's Perelman School of Medicine. He added, "The compelling results from the PERSEVERE study paired with the ease of use and approachability of the AMDS device will undoubtedly expand the ability of all cardiac surgeons to offer a more comprehensive treatment for patients."
Device Overview and Market Opportunity
The AMDS Hybrid Prosthesis is designed to complement hemiarch replacement without adding technical complexity. Its design allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, preserving the native arch for potential future minimally invasive re-interventions. Artivion estimates that approximately 6,000 patients in the U.S. are diagnosed with acute DeBakey Type I dissection annually, representing a $150 million U.S. market opportunity upon PMA approval, which is expected in late 2025.
Company Statements
"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."
About Acute DeBakey Type I Aortic Dissections
Acute DeBakey Type I aortic dissection occurs when the innermost layer of the aorta tears, causing blood to surge through the tear and separate the layers of the aorta. If untreated, mortality can reach approximately 1% per hour and up to 50% within the first 48 hours. The current standard of care, hemiarch repair, often fails to adequately address the remainder of the diseased aorta, leading to complications in both the acute and long-term phases.
