Artivion announced today that it has initiated enrollment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis. The trial is designed to support the company’s forthcoming application to the Food and Drug Administration (FDA) for premarket approval of the AMDS.
The PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial consisting of approximately 100 participants in the U.S., who have experienced an acute DeBakey Type I aortic dissection. Each participant will be followed for up to five years. The combined primary efficacy and safety endpoints will determine the impact of the AMDS hybrid prosthesis on reducing mortality, new disabling stroke, myocardial infarction, and new onset renal failure requiring dialysis, and also re-expansion of the true lumen of the aorta.
Wilson Szeto, MD, chief of cardiovascular surgery at Penn Presbyterian Medical Center, Philadelphia, the PERSEVERE national principal investigator, said: “Acute aortic dissection is a devastating disease with high morbidity and mortality. The surgical treatment is technically demanding. With the PERSEVERE trial, we intend to show the benefits that AMDS brings to patient outcomes and expand the therapy to more surgeons.”
Principal investigator Mohiuddin Cheema, MD, a cardiac surgeon from Hartford Health, Hartford, Connecticut, who implanted the first AMDS in the trial, said: “I am thrilled to be participating in the PERSEVERE study and to have treated the first patient with the AMDS in the USA. Implantation of the device was simple and added minimal time to the surgery. On the post-op CT scan we saw expansion of the true lumen and resolved malperfusion. Additionally, there was no presence of distal anastomotic new entry (DANE), which gives confidence that the aorta will continue to remodel positively over time and decrease the risk of future reoperation.”
Pat Mackin, chairman, president, and chief executive officer of Artivion, said: “If the trial proceeds as planned and meets its endpoints, we believe we can achieve FDA approval for patient access to the AMDS in late 2024 or early 2025.”