Artivion Reveals Groundbreaking Data on AMDS at EACTS Annual Meeting

Artivion Unveils Late-Breaking Data on AMDS Trials at EACTS

Artivion, Inc., a prominent player in the cardiac and vascular surgery sector, announced compelling results from its AMDS trials during the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting held in Copenhagen, Denmark. The presentations marked a notable presence for Artivion, reflecting its dedication to pushing the boundaries of technology in the treatment of aortic diseases.

Key Insights from AMDS Trials

The AMDS PERSEVERE trial results were particularly noteworthy, revealing that 83% of patients with visceral malperfusion and 74% with renal malperfusion saw resolution of these conditions post-implantation of the AMDS device. Dr. Michael Moon, a co-principal investigator of the PROTECT trial and Clinical Associate Professor of Surgery at the University of Alberta, emphasized the positive impact of this data on patient outcomes, especially considering the severity of the conditions being treated.

Pat Mackin, Artivion's Chairman and CEO, expressed his enthusiasm regarding the strong presentation at EACTS, underlining that the trial results confirm the effectiveness of AMDS technology, which continues to improve the lives of critically ill patients.

Detailed Data from the Trials

The AMDS PERSEVERE trial involved 40 participants with acute DeBakey Type I dissections. The findings demonstrated that 83% of individuals with pre-operative visceral malperfusion avoided serious gastrointestinal incidents, such as bowel ischemia and the need for laparotomy. Similarly, 74% of those with renal malperfusion did not face renal failure requiring dialysis.

Furthermore, the analysis included patients without pre-operative symptoms, indicating that AMDS performed consistently well across different risk categories.

On the other hand, data from the AMDS PROTECT trial, focusing on real-world applications, illustrated favorable outcomes among 141 participants, parallel to the results identified in the PERSEVERE and the DARTS trials. The PROTECT trial's findings highlight a disabling stroke rate of 12.6%, suggesting significant improvements compared to the STS Adult Cardiac Surgery Database, which reports rates between 11.2% and 15.6%.

About the Trials

The PERSEVERE trial is a multi-center, non-randomized study aimed at assessing the safety and efficacy of the AMDS Hybrid Prosthesis for patients with acute DeBakey Type I aortic dissections. The study is designed to support Artivion’s forthcoming application to the U.S. Food and Drug Administration (FDA) for premarket approval.

In contrast, the PROTECT trial serves as an observational study assessing the AMDS’s real-world performance. It has enrolled 302 participants across Europe and Canada, with the current analysis focusing on the first 141 patients to reach follow-up evaluations between 3 to 6 months after intervention.

Significance of AMDS Technology

The AMDS device represents a revolutionary advancement in treating acute DeBakey Type I aortic dissections, aiming to rectify complications associated with traditional repair techniques. With approximately 48,000 cases occurring annually within the U.S. alone, the potential market for AMDS is substantial. The device facilitates rapid deployment alongside standard surgical procedures, minimizing operational time and preserving the aortic arch's integrity, which is vital for future interventions.

Ultimately, Artivion continues to lead innovations in the aortic disease treatment landscape, positioning itself as a key contributor to improved surgical outcomes and patient care. As the company pushes forward, the upcoming trials are set to redefine strategies in tackling these life-threatening conditions.