St. Louis surgeon first in world to implant new stent-graft at St. Anthony’s Medical Center
ST. LOUIS – Just before Thanksgiving, St. Louis vascular surgeon Brian Peterson, MD, made history as the world’s first surgeon to successfully implant the iliac branch stent-graft.
The St. Anthony’s Medical Center patient who received the investigational device was the first one enrolled worldwide in the Gore Excluder Iliac Branch Clinical Study to test the safety and effectiveness of the new stent used to treat aortic and iliac aneurysms.
“This new device allows more patients to undergo a less invasive endovascular procedure, which implants the stent through an artery, rather than open surgery,” said Peterson, associate professor of surgery at Saint Louis University (SLU). “The less invasive surgery helps speed up recovery time. This new stent-graft is also designed to preserve vital blood flow to the pelvis by including an additional branch in the stent, compared to the traditional device used now.”
In October, the device maker, W.L. Gore & Associates, won CE Mark approval in the European Union for its Excluder iliac branch stent graft, and is available in the United States for investigational purposes only. Peterson believes the device will “absolutely” be mainstreamed expediently.
“The industry sponsor of the trial is actively undergoing site visits and enrolling centers across the country,” said Peterson, about the U.S. goal of 49 sites for the prospective, multi-center, non-randomized, single-arm study. “We hope that, within a year or so, we’ll have enough patients enrolled in the trial to come up with some conclusions and hopefully make this widely available.”
Gore’s Ryan Takeuchi said the fully engineered system “fulfills an unmet clinical need.”
Peterson concurs. “About 40 percent of patients with abdominal aortic aneurysms also have aortic aneurysms of their iliac arteries,” he said. “This allows us to treat those all in one setting.”
The 767-bed St. Anthony’s Medical Center, one of the largest hospitals in the metro area, with a Level 2 trauma center and four urgent care facilities, became the site of the world’s first surgery of its kind.
“We were in a good relationship with our industry sponsor,” said Peterson. “Most of my work is done at St. Anthony’s, where processes are very streamlined, from the IRB (Investigational Review Board) to the vascular team, which does a high volume of endovascular aneurysm repairs. The industry sponsor of the trial recognized we’d be a good center because of our volume and outcomes. And everything went very smoothly. We set up our site visit in a very timely fashion. We had a couple of patients lined up, and sure enough, ended up being the first ones in the world to implant this device.”
Peterson discussed the case at Gore’s principle investigators’ meeting in late November in New York City. Since then, one other implant has been performed.
“The most exciting aspect for primary care physicians to know about this new device is, prior to the device being available, we’d usually have to sacrifice one of the major blood vessels that supplies blood to the pelvis. Virtually everyone in follow-up had symptoms, as the decreased blood flow most commonly manifested as pain while walking, cramping, and discomfort of the rear. It resulted in the worst case scenario: poor circulation to the intestines. That’s all virtually eliminated with this device. It preserves the blood flow to the pelvis, and patients are able to return to work sooner and resume their daily activities quicker in a symptom-free manner.”
Since 1984, the Gore Medical Products Division has produced vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line reinforcement and sutures. A consistent “Best Company to Work For,” Gore has provided more than 35 million devices worldwide.
Peterson is optimistic about how the Gore iliac branch stent-graft could revolutionize the treatment for abdominal aortic aneurysms.
“There’s great interest across the country as the medical community realizes this is an option for patients that will soon be available closer to home,” he said.
Medical News markets are well represented in the Gore Excluder Iliac Branch Clinical Study. Among the sites being set up for the prospective, non-randomized, single-arm study to test the safety and effectiveness of a new stent used to treat aortic and iliac aneurysms, and the physicians representing them:
Florida Vascular Consultants
Robert Winter, MD
Saint Anthony’s Medical Center
St. Louis, Mo.
Brian Peterson, MD
Ochsner Health System
Department of Surgery
New Orleans, La.
W. Charles Sternbergh III, MD
University of Alabama Medical Center
William D. Jordan Jr., MD
University of Mississippi Medical Center
Division of Vascular Surgery
Zachary K. Baldwin, MD
Vanderbilt University Medical Center
Thomas Naslund, MD
SOURCE: W.L. Gore & Associates.