PERSEVERE Trial of Artivion’s AMDS Hybrid Prosthesis Completes Enrollment

November 9, 2023—Artivion, Inc. announced that it has completed enrollment in the PERSEVERE clinical trial of the AMDS hybrid prosthesis (formerly known as the Ascyrus Medical dissection stent). The device was developed by Ascyrus Medical as an aortic arch remodeling device used for the treatment of acute type A aortic dissection. Ascyrus was acquired by Artivion (formerly known as CryoLife, Inc.) in September 2020.

According to Artivion, the PERSEVERE trial is a prospective, multicenter, nonrandomized clinical trial to determine if patients with 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 FDA for premarket approval (PMA) of the AMDS. The company announced initiation of enrollment in July 2022.

The trial will be composed of 93 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 30-day safety and primary efficacy 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 remodeling 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.

“Congratulations to all the investigators and the entire Artivion team for the completion of the PERSEVERE trial,” commented Dr. Szeto in the company’s press release. “AMDS represents a practice-changing advancement for all cardiothoracic surgeons in the surgical treatment of patients with acute DeBakey type I aortic dissection presenting with malperfusion. Completion of this important trial is an exciting milestone in the field of thoracic aortic surgery.”

Dr. Szeto added, “We are hopeful that the study will be positive and demonstrate AMDS as a transformative innovation that will improve the lives of our patients with this devastating clinical scenario.”

Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion, stated in the press release, “We are incredibly pleased to have completed enrollment in the PERSEVERE clinical trial. We recently presented overwhelmingly positive interim results of the PERSEVERE trial at the European Association of Cardiothoracic Surgery Meeting in Vienna that demonstrated the lifesaving nature of AMDS, including reduction of stroke, new onset renal failure requiring dialysis, and myocardial infraction. The completion of the enrollment of the study keeps us on track to achieve PMA approval in the second half of 2025.”

Artivion advised that AMDS is available in select markets around the world including Europe, Canada, and certain countries in Asia.