Artivion (NYSE:AORT) this week announced it received FDA humanitarian device exemption (HDE) for its AMDS hybrid prosthesis.
The Atlanta-based company said AMDS is the first aortic arch remodeling device to treat acute DeBakey Type I aortic dissections.
An HDE designation allows for commercial distribution of the device in the U.S. before Artivion’s anticipated FDA premarket approval. Under the designation, AMDS will be available as a treatment for acute DeBakey Type I dissections in the presence of malperfusion. Once approved, the device is expected to cover all acute DeBakey Type I dissections with and without malperfusion.
According to Artivion, approximately 6,000 patients in the U.S. are diagnosed with acute DeBakey Type I dissection annually. The condition is an emergent, life-threatening medical condition that requires immediate surgical repair.
The current standard of care for the condition is an ascending replacement or hemiarch repair. The procedure can successfully remove the primary entry tear, but Artivion says it doesn’t address the remainder of the diseased aorta, causing complications in the acute and long-term phases.
More about the Artivion device and its performance
In the PERSEVERE U.S. IDE trial, the device demonstrated significant reductions in mortality and major adverse events (MAE) compared to the current standard of care.
It enrolled 93 U.S. patients and achieved its primary endpoints with a 72% reduction in all-cause mortality and a 54% reduction in primary MAEs at 30 days post-implantation. There were no cases of distal anastomotic new entry in AMDS-treated patients, an improvement over the 45% rate observed with the hemiarch procedure.
Dr. Wilson Szeto, chief of cardiovascular surgery at the University of Pennsylvania, presented these findings at the Society of Thoracic Surgeons (STS) Annual Meeting. Other trial results 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- All-cause mortality: 9.7% (vs. 34.6% historical reference)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: 0.0% (vs. 45%)
“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. 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,” Szeto said in a news release.
The AMDS is the first aortic arch remodeling device for acute DeBakey Type I aortic dissections, complementing hemiarch replacement while preserving the native aortic arch for future interventions. The device is already approved in select global markets, including Europe and Canada.
The PERSEVERE trial’s long-term follow-up will further assess safety and efficacy, with endpoints addressing aortic remodeling, mortality, and key complications.
“This HDE from the FDA validates the groundbreaking nature of AMDS, a device with no comparable clinical alternative,” CEO Pat Mackin said. “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.”
