Artivion AMDS Evaluated in PERSEVERE Trial

January 27, 2025—Artivion, Inc. announced the presentation of clinical data from the PERSEVERE United States investigational device exemption (IDE) trial of the company’s AMDS hybrid prosthesis.

PERSEVERE 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 device. The trial is designed to support the company’s forthcoming application to the FDA for premarket approval of the AMDS. The IDE trial is composed of 93 patients in the United States who have experienced an acute DeBakey type I aortic dissection complicated by malperfusion. The patients will be followed for up to 5 years.

According to the company, the data analyzed clinical outcomes across the full study cohort of 93 patients at 1 year after implantation of the AMDS device.

The PERSEVERE trial met its primary endpoints and demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events (MAEs), with zero occurrence of distal anastomotic new entry (DANE), when compared to the current standard of care hemiarch procedure at 30 days after AMDS implantation, advised Artivion.

Shinichi Fukuhara, MD, presented the findings in a late-breaking science presentation at the 61st annual meeting of the Society of Thoracic Surgeons held January 24-26 in Los Angeles, California. The study abstract was titled “1-Year Results of a Novel Aortic Arch Hybrid Prosthesis for Open Repair of Acute DeBakey Type I Dissection with Malperfusion in the PERSEVERE Study.” Dr. Fukuhara is with the Division of Cardiac Surgery at the University of Michigan in Ann Arbor, Michigan.

Artivion stated that data from the IDE trial demonstrated sustained benefit of AMDS out to 1 year, with minimal new occurrence of stroke, renal failure requiring dialysis, or myocardial infarction. Additionally, 80% of patients survived through 1 year, with mortality after 30 days attributed to comorbidities and dissection-related complications.

Further, the company reported that core lab analysis of follow-up CT scans suggested that AMDS prevents the occurrence of DANE tears, which compares favorably to expected rates of early reintervention and DANE tears in this patient population.

As noted in the press release, DANE tears occur in up to 70% of patients after hemiarch repair without AMDS, allowing continued blood flow into the false lumen created by the dissection. The presence of DANE is associated with enlargement of the aorta, reoperation, and increased mortality. In contrast, DANE has not been detected in any patients in the PERSEVERE study and it was not reported in the DARTS study through 5 years of follow-up of AMDS-treated patients. The need for unanticipated aortic reoperations was low at 4.3%, reported Artivion.

As outlined in the company’s press release, the primary endpoints for PERSEVERE (N = 93) versus historical controls at 30 days and 1 year, respectively, were the following:

• All-cause mortality: 9.7% versus 34.6% and 20.4% versus 42.7%
• New disabling stroke: 10.8% versus 20.9% and 11.8% versus not reported (NR]
• New renal failure/dialysis: 19.4% versus 24.1% and 20.4% versus NR
• Myocardial infarction: 0% versus 10.5% and 2.2% versus NR
• Total number with ≥ one MAE: 26.9 versus 58 and 30.1 versus NR
• DANE: 0% versus 45% and 0% versus NR

“Patient outcomes following AMDS treatment of acute DeBakey type I aortic dissection with malperfusion remain impressive through 1 year after operation,” commented Dr. Fukuhara in Artivion’s press release. “AMDS is an important tool for cardiovascular surgeons in treating this devasting disease.”

Artivion stated that the AMDS is an aortic arch remodeling device for use in the treatment of acute DeBakey type I aortic dissections. It is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity.

AMDS is available in the United States under a humanitarian device exemption, which was approved in December 2024. It is also available in select markets around the world, including Europe (where it was approved in 2019), Canada, and certain countries in Asia.

In the DARTS clinical trial supporting the CE Mark approval and Health Canada approval approvals, the AMDS was shown to reduce complications and reoperations in comparison to published rates with the standard of care, thereby improving the care of patients and offering potential cost savings for the health care system, stated Artivion.