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Artivion Announces Presentation of Late-Breaking Data from AMDS PERSEVERE and AMDS PROTECT Trials at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting
Prnewswire· 2025-10-13 12:00
Core Insights - The AMDS PERSEVERE trial demonstrated a resolution of visceral malperfusion in 83% and renal malperfusion in 74% of affected subjects after AMDS implantation, indicating significant clinical efficacy [2][4][7] - Real-world data from the AMDS PROTECT trial corroborated the positive outcomes observed in the PERSEVERE trial, showcasing excellent clinical results consistent with previous studies [6][9] AMDS PERSEVERE Trial Findings - The trial focused on patients with acute DeBakey Type I aortic dissection and assessed the effectiveness of the AMDS hybrid prosthesis in resolving visceral and renal malperfusion [4][8] - Among the 40 study participants, 83% with pre-operative visceral malperfusion did not experience significant gastrointestinal events, and 74% with renal malperfusion did not require dialysis [7][8] AMDS PROTECT Trial Findings - The PROTECT trial included 141 patients and reported outcomes such as a 12.6% rate of disabling stroke and a 4.2% rate of renal failure requiring dialysis, both of which are significantly lower than the rates in the STS Adult Cardiac Surgery Database [6][9] - The trial also noted no occurrences of paralysis, aortic rupture, or myocardial infarction, with 95.3% to 100% of patients experiencing positive remodeling of the aorta [6][9] Company Statements - Dr. Michael Moon emphasized the importance of the AMDS technology in improving outcomes for critically ill patients [3] - Pat Mackin highlighted the strong presence of the company at the EACTS meeting and reaffirmed the commitment to innovation in aortic disease treatment [3] Market Opportunity - Approximately 48,000 patients suffer from acute DeBakey Type I aortic dissections annually, representing a market opportunity of $150 million in the U.S. and $540 million globally [11]