Artivion, known by its NYSE ticker symbol AORT, recently revealed it has secured a humanitarian device exemption (HDE) from the FDA for its innovative AMDS Hybrid Prosthesis.
Based in Atlanta, the company highlighted that the AMDS is pioneering as the first aortic arch remodeling device specifically for managing acute DeBakey Type I aortic dissections.
With an HDE classification, Artivion can commercially introduce the device within the U.S. prior to achieving anticipated FDA premarket approval. This classification enables the availability of the AMDS as a solution for acute DeBakey Type I dissections accompanied by malperfusion. Following approval, it is projected that the device will be applicable to all cases of acute DeBakey Type I dissections, irrespective of malperfusion.
Artivion estimates around 6,000 individuals in the U.S. annually face a diagnosis of acute DeBakey Type I dissection, a severe and urgent medical condition necessitating prompt surgical intervention.
Traditionally, the treatment involves ascending replacement or hemiarch repair, effective at addressing the initial tear but, according to Artivion, failing to tackle the extent of the diseased aorta, potentially leading to acute and long-term complications.
Device Performance Insights
The PERSEVERE U.S. IDE trial showcased the device’s positive impact, including reduced mortality and major adverse events (MAE) in comparison to traditional care methods.
The trial enrolled 93 patients nationwide, demonstrating a significant 72% drop in all-cause mortality and a 54% decline in primary MAEs 30 days post-implant. Notably, there were zero cases of distal anastomotic new entries in patients treated with the AMDS, a noteworthy improvement from the 45% incidence observed with the hemiarch method.
Dr. Wilson Szeto, heading Cardiovascular Surgery at the University of Pennsylvania, shared these outcomes at the Society of Thoracic Surgeons (STS) Annual Meeting. Further trial findings include:
- All-cause mortality: 9.7% versus 34.6% in historical datasets
- New disabling stroke: 10.8% compared to 20.9%
- Onset of renal failure requiring dialysis: 19.4% against 24.1%
- Myocardial infarction: 0.0% against 10.5%
- Distal anastomotic new entry: 0.0% versus 45%
“The FDA’s acknowledgment of the AMDS device via the HDE route is promising and attests to the unique qualities of the device in addressing a rare and urgent condition,” Szeto stated in a press release. “The convincing results from the PERSEVERE study, combined with the AMDS device’s user-friendliness, are set to enhance cardiac surgeons’ capabilities in providing a more thorough treatment to patients.”
The AMDS represents the inaugural aortic arch remodeling device designed for acute DeBakey Type I aortic dissections, augmenting the hemiarch replacement while maintaining the native aortic arch for potential future interventions. The device already holds approvals in select international markets, including Europe and Canada.
PERSEVERE’s ongoing long-term follow-up will extend evaluations of safety and efficacy, targeting metrics like aortic remodeling, mortality, and critical complications.
According to CEO Pat Mackin, “This HDE from the FDA acknowledges the innovative nature of AMDS, a device unparalleled in clinical application. We are committed to working closely with U.S. facilities and physicians to broaden access to this life-saving device as we progress toward PMA approval, anticipated in late 2025. Our gratitude goes to every PERSEVERE investigator and participant for their role in advancing this groundbreaking technology.”