ATLANTA, Ga., June 29, 2026
Artivion, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its AMDS Hybrid Prosthesis, marking a major advancement in the treatment of acute DeBakey Type I aortic dissections complicated by clinical or radiographic malperfusion. The approval expands patient access to the world’s first aortic arch remodeling device, eliminating the requirement for hospitals to obtain Institutional Review Board (IRB) approval previously associated with the Humanitarian Device Exemption (HDE). By removing this administrative barrier, physicians across the United States can immediately offer the innovative technology to eligible patients suffering from one of the most life-threatening cardiovascular emergencies. The PMA approval is supported by strong clinical evidence from the PERSEVERE U.S. Investigational Device Exemption (IDE) trial, which demonstrated substantial improvements in survival and reductions in major adverse clinical events compared with conventional hemiarch repair. The milestone strengthens Artivion’s leadership in advanced aortic surgery technologies while expanding access to a transformative medical device designed to improve outcomes for patients facing complex aortic disease.
Clinical Trial Demonstrates Significant Survival and Safety Benefits
The AMDS Hybrid Prosthesis was specifically developed to complement standard hemiarch replacement surgery without adding technical complexity while addressing limitations associated with current surgical approaches. According to results from the PERSEVERE clinical trial, the device achieved a 72% reduction in all-cause mortality and a 54% reduction in major adverse events, including stroke, myocardial infarction, and renal failure requiring dialysis, compared with standard hemiarch repair. Importantly, investigators also reported zero distal anastomotic new entry (DANE) tears, a serious complication that frequently occurs following conventional surgical repair and increases the risk of future interventions.
Long-term follow-up data presented at the 62nd Annual Meeting of the Society of Thoracic Surgeons further demonstrated sustained clinical durability, including stable aortic dimensions, continued expansion of the true lumen, absence of new DANE tears, and no unexpected aortic reoperations over two years. These findings reinforce the potential of AMDS to significantly improve both immediate surgical outcomes and long-term patient prognosis.
Innovative Aortic Technology Expands Access to Life-Saving Care
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Each year, approximately 6,000 patients in the United States experience an acute DeBakey Type I aortic dissection, a rapidly progressing cardiovascular emergency associated with mortality rates approaching 50% within 48 hours if left untreated. Traditional surgical repair addresses the primary tear but often leaves residual disease throughout the aorta, increasing the risk of future complications including aneurysm formation, organ malperfusion, and repeat surgery. The AMDS Hybrid Prosthesis introduces a novel aortic arch remodeling strategy that preserves the native aortic arch while allowing minimally invasive future interventions when necessary. Following successful commercial introduction under the HDE pathway, the new PMA approval enables broader nationwide adoption and positions Artivion to address an estimated $150 million annual U.S. market opportunity. The approval also strengthens the company’s expanding portfolio of advanced aortic repair technologies, complementing recent innovations and ongoing clinical development programs.
By combining innovative device engineering with compelling long-term clinical evidence, Artivion continues to redefine modern aortic surgery through technologies that improve survival, reduce postoperative complications, and enhance long-term patient outcomes. The FDA approval of the AMDS Hybrid Prosthesis represents a significant milestone in cardiovascular medical technology, offering cardiac and vascular surgeons an advanced solution capable of transforming the standard of care for one of the most challenging and life-threatening forms of aortic disease.
Source: Artivion press release
