Artivion granted US FDA humanitarian device exemption for the AMDS hybrid prosthesis

Artivion recently announced that the US Food and Drug Administration (FDA) has granted a humanitarian device exemption (HDE) for use of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent) in acute DeBakey type I dissections in the presence of malperfusion.

A press release notes that the AMDS is the world’s first aortic arch remodelling 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). Artivion details that 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 USA 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 USA. The PMA, if approved, is expected to cover all acute DeBakey type I dissections with and without malperfusion, representing an estimated US$150 million annual US market opportunity.

The HDE for AMDS was granted following the availability of full cohort data from the PERSEVERE US investigational device exemption (IDE) trial for AMDS. The trial consisted of 93 participants in the USA 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. Wilson Szeto, chief of cardiovascular surgery at Perelman School of Medicine at the University of Pennsylvania in Philadelphia, USA, recently presented the data from the PERSEVERE US IDE trial as a late-breaking abstract at the Society of Thoracic Surgeons (STS) annual meeting (primary endpoint results reported below).

Szeto said: “The fact that the FDA has recognised 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 USA 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.”

Mackin added: “We are excited to start laying the groundwork for this launch over the coming weeks and months by obtaining hospital IRB [institutional review board] approvals, a requirement of the HDE, submitting to hospital value analysis committees (VAC) and training surgeons. This will position us to begin penetrating the US$150 million US market opportunity available upon PMA approval as we move through 2025.”