Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for use of the AMDS Hybrid Prosthesis (“AMDS”) in acute DeBakey Type I dissections in the presence of malperfusion. The AMDS is the world’s first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections.
An HDE is a marketing application for a product that has been designated a Humanitarian Use Device (HUD). AMDS received both HUD and Breakthrough Designation, due to its intended benefit for patients in the treatment or diagnosis of a rare disease or condition in which no other comparable options currently exist. The HDE allows for commercial distribution of AMDS in the United States prior to anticipated approval of a Premarket Approval (“PMA”) 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 U.S. The PMA, if approved, is expected to cover all acute DeBakey Type I dissections with and without malperfusion, representing an estimated $150 million annual US market opportunity.
Each year, approximately 6,000 patients in the U.S. present with an acute DeBakey Type I dissection, an emergent, life-threatening medical condition that requires immediate surgical repair. Left untreated, mortality from such a dissection is reported to be approximately 1% per hour and up to 50% in the first 48 hours. Today the standard of care is an ascending replacement or hemiarch repair. While this procedure can successfully remove the primary entry tear, it fails to adequately address the remainder of the diseased aorta, resulting in complications in both the acute and long-term phases.
The HDE for AMDS was granted following the availability of full cohort data from the PERSEVERE US IDE trial for AMDS. 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. Dr. Wilson Szeto, Chief of Cardiovascular Surgery at Perelman School of Medicine at the University of Pennsylvania, recently presented the data from the PERSEVERE US IDE trial as a late-breaking abstract at the STS Annual meeting (primary endpoint results reported below).
Dr. Szeto said, “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.”
“This HDE from the FDA validates the groundbreaking nature of AMDS, a device with no comparable clinical alternative,” said Pat Mackin, Chairman, President, and Chief Executive Officer 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.”
