Artivion Granted FDA Humanitarian Device Exemption for AMDS Hybrid Prosthesis

December 9, 2024—Artivion, Inc. announced that the FDA has granted a humanitarian device exemption (HDE) for use of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent), an aortic arch remodeling device for acute DeBakey type I dissections in the presence of malperfusion.

The company noted that the AMDS has received both Humanitarian Use Device (HUD) and Breakthrough Device designation, which are granted by the FDA for devices’ intended benefit for patients in the treatment or diagnosis of a rare disease or condition in which no other comparable options currently exist. HDE, which is a marketing application for a product that has received both HUD and Breakthrough Device designations, allows for commercial distribution of AMDS in the United States before the anticipated approval of a premarket approval application.

Under the HDE, AMDS will be available as a treatment for acute DeBakey type I dissections in the presence of malperfusion, which represent approximately 40% of all acute DeBakey type I dissections in the United States. The PMA, if approved, is expected to cover all acute DeBakey type I dissections with and without malperfusion, advised Artivion.

According to the company, the HDE for AMDS was granted after the full cohort data from the PERSEVERE United States investigational device exemption trial for AMDS became available.

The PERSEVERE trial was composed of 93 patients in the United States. The trial 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 after AMDS implantation.

The PERSEVERE trial data were presented by Wilson Szeto, MD, at STS 2024, the 60th annual meeting of the Society of Thoracic Surgeons held January 27-29 in San Antonio, Texas. Dr. Szeto, who serves as National Principal Investigator and Chair of the Steering Committee for the PERSEVERE trial, is Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center in Philadelphia, Pennsylvania.

The company stated that the PERSEVERE data showed that use of AMDS resulted in 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.

As outlined in the company’s press release, the PERSEVERE data compared to the historical reference for primary major adverse events (MAEs) was 26.9% vs 58.0%. Individual MAE data included all-cause mortality, 9.7% vs 34.6%; new disabling stroke, 10.8% vs 20.95; new onset renal failure requiring dialysis,19.4% vs 24.1%; myocardial infarction, 0.0% vs 10.5%; and DANE, 0.0 vs 45.0.

“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,” commented Dr. Szeto in the company’s press release. “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.”

As previously noted, AMDS is available in Canada and in the markets that recognize European CE Mark approval. CE Mark approval was announced in February 2019. In the DARTS clinical trial supporting CE Mark and Health Canada approvals, the AMDS was shown to reduce complications and reoperations in comparison to published rates with the standard of care, thereby improving the care of patients and offering potential cost savings for the health care system.