Artivion Initiates PERSEVERE Clinical Trial of AMDS Hybrid Perfusion Device

July 27, 2022—Artivion, Inc., a cardiac and vascular surgery company focused on aortic disease, announced 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 (formerly known as the Ascyrus Medical dissection stent). The trial is designed to support the company’s forthcoming application to the FDA for premarket approval of the AMDS.

Artivion was formerly known as CryoLife, Inc. In January 2022, CryoLife announced its renaming and rebranding as Artivion. In September 2020, CryoLife announced the acquisition of privately held Ascyrus Medical, which developed the AMDS as an aortic arch remodeling device used for the treatment of acute type A aortic dissection.

According to Artivion, PERSEVERE is a prospective, multicenter, nonrandomized clinical trial composed of approximately 100 patients in the United States who have experienced an acute DeBakey type I aortic dissection. Each patient will be followed for up to 5 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, as well as reexpansion of the true lumen of the aorta.

Wilson Szeto, MD, serves as the PERSEVERE National Principal Investigator and Chair of the Steering Committee. Dr. Szeto is Chief of Cardiovascular Surgery at Penn Presbyterian Medical Center in Philadelphia, Pennsylvania.

“Acute aortic dissection is a devastating disease with high morbidity and mortality,” commented Dr. Szeto in Artivion’s press release. “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.”

The first implantation of an AMDS in the trial was conducted by cardiovascular surgeon Mohiuddin Cheema, MD, who is the Principal Investigator for PERSEVERE at Hartford Health in Hartford, Connecticut.

Dr. Cheema stated in the press release, “I’m thrilled to be participating in the PERSEVERE study and to have treated the first patient with the AMDS in the United States. 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, 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, stated, “We are pleased to announce that the first patient in our PERSEVERE clinical trial has been enrolled at Hartford Hospital. Through the PERSEVERE trial, we will study the safety and efficacy of the AMDS to treat patients suffering from acute DeBakey type I aortic dissections, a life-threatening condition characterized by extremely high mortality rates.”

Mr. Mackin added, “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.”

The company further noted that AMDS is available in Canada and in the markets that recognize European CE Mark approval. In the clinical trial supporting the Health Canada and CE Mark approvals, the AMDS was shown to reduce mortality, complications, and reoperations in comparison to published rates with the standard of care, thereby improving the care of patients and offering potentially significant cost savings for the health care system. CE Mark approval was announced in February 2019.

The AMDS is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity. The device’s design allows for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, adding < 5 minutes to the procedure time. The deployment of the AMDS preserves the native arch, potentially allowing for minimally invasive reinterventions, including the repair of additional entry tears, rather than an invasive arch repair, advised Artivion.