Artivion has secured a green light from the FDA for its stentlike implant designed to help remodel the interior of the aortic arch following rare and severe tears within the lining of the major blood vessel.
The agency granted a humanitarian device exemption to the company’s AMDS Hybrid Prosthesis to help treat what are called acute DeBakey type I aortic dissections—where the innermost layer begins to pull away from the aortic wall, starting in the ascending side of the arch and then continuing around down through the descending side—and specifically those that hamper the flow of oxygenated blood to the rest of the body’s organs.
The AMDS is employed as part of a standard open procedure to replace about half of the ascending arch and the initial tear with a synthetic graft. After being sewn in place, the implant extends downstream into the descending aorta before expanding to hold open the remaining, detached lumen and help keep blood from leaking into exterior layers and pockets.
“This HDE from the FDA validates the groundbreaking nature of AMDS, a device with no comparable clinical alternative,” Artivion President and CEO Pat Mackin said in a statement. “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 [premarket approval], which we still expect in late 2025.”
HDE authorizations are reserved by the FDA for devices aimed at rare conditions; Artivion estimates that about 6,000 people in the U.S. per year are affected by acute DeBakey type I dissections—of which, if left untreated, as many as 50% of patients can die within 48 to 72 hours.
The Atlanta-based company’s PMA application aims to cover all acute DeBakey type I dissections, both with and without associated malperfusion, in procedures predicted to be a $150 million U.S. market. Globally, about 48,000 patients suffer from the condition annually.
“We are excited to start laying the groundwork for this launch over the coming weeks and months by obtaining hospital IRB approvals, a requirement of the HDE, submitting to hospital value analysis committees and training surgeons,” Mackin said.
Earlier this year, a clinical study analyzing blood flow to the brain among 93 patients who received the AMDS prosthesis showed 90% of participants had their cerebral malperfusion resolved after 30 days.
The PERSEVERE trial also showed a rate of disabling strokes of 10.8% and all-cause mortality of 9.7%. Compared to data gathered from historical control groups, those rates can top 20% and 34%, respectively, according to Artivion.
“Cerebral malperfusion, which often leads to stroke, is a devastating complication of acute DeBakey type I aortic dissection,” the study’s senior author, William Brinkman, M.D., of the Heart Hospital in Plano, Texas, said in October amid presentations at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon. “The data from the PERSEVERE trial indicating that AMDS markedly reduces 30-day malperfusion and new disabling stroke compared to the baseline, is very encouraging.”
A separate study presented at EACTS showed that 94% of patients who received AMDS did not require aortic reoperations out to five years.