Artivion Inc. presented compelling late-breaking data from two pivotal clinical trials of its AMDS Hybrid Prosthesis at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Copenhagen, demonstrating significant improvements in treating acute DeBakey Type I aortic dissections. The results showcase the device's effectiveness in resolving life-threatening malperfusion complications that affect some of the most critically ill cardiac patients.
PERSEVERE Trial Demonstrates High Malperfusion Resolution Rates
The AMDS PERSEVERE trial's 30-day data revealed remarkable outcomes in patients presenting with visceral and renal malperfusion. Among the 40 study participants with clinical malperfusion, 83% of patients with pre-operative visceral malperfusion avoided significant gastrointestinal complications, including bowel ischemia, ileus, bleeding, abdominal pain, need for laparotomy, or artery stenting.
For renal complications, 74% of patients with pre-operative renal malperfusion did not develop renal failure requiring dialysis or need for artery stenting, with all patients achieving radiographic resolution. The analysis found no meaningful difference in clinical outcomes between patients with and without pre-operative symptomatic malperfusion, demonstrating consistent AMDS performance even in higher-risk patients.
"The latest data from these two ongoing long-term studies of AMDS continue to highlight how this critical technology is improving outcomes for some of our sickest patients," said Dr. Michael Moon, Clinical Associate Professor of Surgery at University of Alberta, Canada, and steering committee member of the PERSEVERE trial.
Real-World PROTECT Registry Validates Clinical Benefits
The AMDS PROTECT trial presented real-world data from 141 patients across European and Canadian centers, demonstrating outcomes that significantly outperformed standard care benchmarks. The registry showed substantially lower complication rates compared to the STS Adult Cardiac Surgery Database: disabling stroke occurred in 12.6% versus 11.2-15.6%, renal failure requiring dialysis in 4.2% versus 12.4-25.1%, and unanticipated reoperation in just 1.4% versus 16.3-25.4%.
Notably, the PROTECT registry recorded zero occurrences of paralysis/paraparesis, aortic rupture, or myocardial infarction. Between 95.3% and 100% of patients experienced positive remodeling with true lumen diameter increasing or remaining stable across zones 1, 2, and 3.
Revolutionary Device Addresses Critical Unmet Need
The AMDS represents the world's first aortic arch remodeling device specifically designed for acute DeBakey Type I aortic dissections. The device complements standard hemiarch replacement without adding technical complexity, allowing rapid deployment during ascending aorta replacement with minimal additional procedure time.
Previous PERSEVERE trial results supporting the FDA premarket approval application demonstrated a 72% reduction in all-cause mortality and 54% reduction in primary major adverse events compared to standard hemiarch procedures at 30 days, with zero occurrence of distal anastomotic new entry (DANE) tears.
Addressing a Significant Global Health Challenge
Acute DeBakey Type I aortic dissections affect approximately 48,000 patients globally each year, representing a $150 million market opportunity in the United States and $540 million globally. These dissections occur when the aorta's innermost layer tears, with the dissection flap originating in the ascending aorta and extending into the descending thoracic aorta.
Left untreated, aortic dissections prove fatal in approximately half of patients within three days. Current standard hemiarch repair, while addressing immediate critical issues, often fails to prevent downstream complications including malperfusion and continued false lumen flow leading to aneurysmal growth.
Clinical Trial Design and Regulatory Path
The PERSEVERE trial is a prospective, multicenter, non-randomized study of 93 U.S. participants with acute DeBakey Type I aortic dissection complicated by malperfusion, with follow-up extending to five years. The trial met its combined safety and primary efficacy endpoints, supporting Artivion's forthcoming FDA premarket approval application.
The PROTECT trial serves as a real-world, observational study investigating AMDS performance across 302 participants in Europe and Canada, with the current presentation covering 141 patients who reached 3-6 month follow-up.
"We were thrilled to command such a strong presence at EACTS with data from our AMDS clinical trials featured in two late-breaking science sessions," said Pat Mackin, Chairman, President, and Chief Executive Officer of Artivion. "These results further validate the strength of our best-in-class portfolio and reinforce our commitment to advancing innovation in the treatment of aortic disease."
