Artivion, Inc. (NYSE: AORT) has announced that the U.S. Food and Drug Administration (FDA) has granted a humanitarian device exemption (HDE) for the use of the AMDS hybrid prosthesis in acute debakey type I dissections in the presence of malperfusion. The HDE allows for commercial distribution of AMDS in the United States prior to anticipated approval of a premarket approval (PMA) application. The AMDS received both humanitarian use device (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 company revealed that the HDE for AMDS was granted following the availability of full cohort data from the Persevere US IDE trial for AMDS. The trial, which consisted of 93 participants in the U.S., met its primary endpoints by demonstrating a 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. Data from the trial showed 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.
The AMDS is the world's first aortic arch remodeling device for use in the treatment of acute debakey type I aortic dissections. It is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity. The design of the AMDS allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, with deployment adding minimal time to the procedure. The deployment of the AMDS preserves the native arch, allowing for minimally invasive re-interventions if needed, rather than an invasive arch repair.
Artivion revealed that the HDE from the FDA validates the groundbreaking nature of AMDS, a device with no comparable clinical alternative. The company is now planning to work diligently with facilities and physicians in the U.S. to expand access to this life-saving device as they continue to work towards PMA approval, which is expected in late 2025.
In terms of the market opportunity, the PMA, if approved, is expected to cover all acute debakey type I dissections with and without malperfusion, representing an estimated $150 million annual U.S. market opportunity. Globally, approximately 48,000 patients suffer annually from acute debakey type I aortic dissections, representing an estimated $150 million market opportunity in the United States and a $540 million market opportunity globally, pending regulatory approvals.
Artivion, Inc. is a medical device company focused on developing solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's products include aortic stent grafts, surgical sealants, on-x mechanical heart valves, and implantable cardiac and vascular human tissues, and the company markets and sells products in more than 100 countries worldwide. As a result of these announcements, the company's shares have moved -3.0% on the market, and are now trading at a price of $28.79. If you want to know more, read the company's complete 8-K report here.
