In 1954, Dr. Michael DeBakey transformed vascular surgery with a homemade Dacron graft sewn on his wife’s sewing machine. His spirit of innovation laid the foundation for decades of U.S.-led advancement in aortic technology. However, recent trends suggest that this pioneering role is eroding, in large part due to the unintended consequences of regulatory tightening by the Food and Drug Administration (FDA).
The 2015 introduction of the custom medical device (CMD) and investigational device exemption (IDE) revision clause, which requires physician-sponsored IDEs for the use of physician-modified endografts (PMEGs), was intended to formalize oversight and ensure patient safety. But for many in the vascular surgery community, it has become a symbol of bureaucratic overreach that is obstructing progress. The U.S. regulatory burden now stands in stark contrast to the more permissive environments abroad, where innovation in complex endovascular aortic surgery has found fertile ground. To understand this shift, we conducted a scoping review—conducted with data gathering by research fellow Georges Jreij, MD, and medical student Jeffrey Lu, BS, and co-authored by Saurabh Gupta, MD, Khanjan Nagarsheth, MD, Mehrdad Ghoreishi, MD—of 5,197 articles addressing branched, fenestrated or physician-modified endografts, of which 263 met inclusion criteria. The majority (81%) were published after 2015, coinciding with the implementation of the CMD and IDE clause. Before 2015, the U.S. produced nearly 45% of these studies. After 2015, that share dropped to 24.3%, with China, Italy, Germany and Japan all increasing their output significantly. Interestingly, China went from a negligible presence to contributing nearly 14% of publications—an astonishing rise.
The shift is even more pronounced when comparing article types. Prior to 2015, 41% of U.S. publications were clinical trials; this fell to just 6% after 2015. Meanwhile, case reports and series rose to comprise 52% of post-2015 U.S. publications. For the rest of the world, this transition was even more dramatic, with case reports and series comprising 59% of studies post-2015. This increase in lower-tier evidence—while perhaps criticized by some—also reflects where the frontier of innovation is occurring: at the bedside, in real time, unencumbered by regulatory inertia.
Patient volume data echoed this trend. Before 2015, U.S.- based publications represented 66% of all patients treated with advanced endovascular techniques. After 2015, the U.S. share dropped to 52%, while the rest of the world saw a fourfold increase in treated patients—nearly matching the U.S. total. Innovation, quite literally, has moved offshore.
This is not just a matter of publication metrics or national pride. It affects patients and surgeons alike. Only about 10 U.S. sites currently have access to custom-made endografts under IDE protocols, despite the presence of more than 3,000 practicing vascular surgeons across 400 medical centers. The remaining majority are left waiting— not because of a lack of training or need, but because of systemic barriers that favor prolonged clinical trials over physician-led adaptability.
Meanwhile, many of the companies producing these devices are based in the U.S. but now conduct early feasibility studies overseas. The result is that U.S. vascular surgeons are increasingly reliant on global colleagues to define the future of their specialty. While large, structured U.S.-based trials continue to provide high-quality data, they do so at the cost of speed, accessibility, and real-time iteration.
If we are to restore balance between regulation and innovation, one potential solution lies in expanding the role of real-world data collection through established registries. The Vascular Quality Initiative (VQI) and Society of Thoracic Surgeons (STS) databases could be leveraged to track advanced aortic procedures, providing post-market surveillance while allowing broader clinical access. This model has already proven successful in the case of transcarotid artery revascularization (TCAR), which received FDA clearance through VQI-based monitoring. A similar path could allow PMEGs and CMDs to break free of current constraints.
Dr. DeBakey didn’t wait for approval to innovate. He took the initiative, using available tools to solve urgent clinical problems. Today, many of us feel constrained from doing the same—not because we lack ideas or skill, but because we are fenced by red tape. If the U.S. hopes to reclaim its leadership in aortic innovation, we must embrace a more pragmatic, data-informed regulatory pathway—one that enables progress without compromising safety.
Without change, the risk isn’t just falling behind; it’s becoming irrelevant.
Shahab Toursavadkohi, MD, is an associate professor of surgery and co-director of the Aortic Center at the University of Maryland.
