An investigational device invented at Sanford Health that helps high-risk vascular disease patients has been granted a breakthrough device designation by the U.S. Food and Drug Administration because it fills an unmet need.
Patrick Kelly, M.D., a Sanford Health vascular surgeon, invented the aortic stent graft system designed to treat a thoracoabdominal aortic aneurysm, or TAAA. That is a complex condition that causes a dangerous bulging of the aorta extending from the chest down into the abdomen. It typically involves the branch arteries that supply blood to multiple internal organs. Left untreated, the aneurysm can rupture and cause sudden death.
The standard of care is complex open surgery, which is associated with a high rate of complications and mortality, and 40% of patients are not considered candidates for open surgical repair.
Dr. Kelly’s concept has the potential to treat more of those people utilizing his minimally invasive approach. Under a physician-sponsored investigational device exemption, or PS-IDE, he has treated more than 150 patients at Sanford Health over the past nine years who otherwise had no other options.
That unmet need, leaving some patients with no other option, was key to the breakthrough device designation, said Katie Pohlson, senior director of innovation and commercialization at Sanford Health.
“With it, we will receive prioritized reviews, access to senior staff at the FDA and collaboration with the FDA to help with the development of the product,” she said.
Collaboration in clinical trial
Rather than go it alone, Sanford Health has developed a streamlined process that allows more surgeons to study the device and more patients to be treated with it under a clinical trial.
Among the other health systems taking part: New York University, Massachusetts General Hospital, University of Southern Florida, Vanderbilt University, The Christ Hospital and The Johns Hopkins Hospital.
“We’ve helped bring all of those sites together to have a common database that we’re collecting and analyzing. And we’re also taking our lessons learned from a case in New York and applying it to a case Sioux Falls, for example, and just learning together as we go through it,” Pohlson said.
The approach isn’t unique, but the results of the collaboration are.
“We’ve just done a good job of establishing this network of independent PS-IDE sites and bringing it further than most people. Most people just focus on one individual site,” she said. “We’ve been able to build a team of cooperative investigators to bring this forward.”
One of them, Geoffrey Answini, M.D., a cardiothoracic surgeon at The Christ Hospital in Cincinnati hopes to soon be able to offer the stent graft to his patients. He recently spent two days with Dr. Kelly learning how to build and deploy the device.
“Dr. Kelly and his team have been gracious enough to help train us to fix these aneurysms so that we can help people in our region that may not have the means to make it all the way out here to South Dakota to get repaired,” he said. “It really is a big benefit not just to the patients but to their families as well if they can get it done closer to home.”
The goal is to evaluate the potential to provide patients with TAAA access to a minimally invasive treatment, while also evaluating how the aortic stent graft works in a real-world population. The net effect will be to lower the risks of the technology and help determine patient selection for a larger trial.
“This way we learn, ‘Who should we be treating with this device? What kind of outcomes can we expect? What should we be looking at when we look at market approval? How should we roll this out?’” Pohlson said.
The nontraditional approach has drawn questions from other health care systems on how to obtain a PS-IDE and quickly gather clinical data on the feasibility of the device.
“The thing that’s unique with what we’re doing is we’ve really taken this from a physician-modified device and it’s now being further developed by industry. We’ve helped set the stage for running these independent studies and provided these templates to other sites, so they can have the same success we’ve had in running an independent trial and pooling all of that data together in a consistent manner,” she said.
“It can be pooled together to get common results that can be compared and analyzed as one cohesive cohort, instead of multiple kind of choppy pieces where maybe one site is collecting one piece of data and another site is collecting it in another way. We’ve really standardized the approach to data collection, patient selection, outcomes that we’re looking at in the study.”
In a house, if a pipe has a hole in it or is clogged, the solution is to reline the pipe. In arteries and veins, an aortic stent graft does the same thing for an aneurysm.
Dr. Kelly said most competing devices all try to mimic the aorta but often don’t fit because the artery is contorted. “The problem with that is we’re trying to fix something abnormal,” he said.
The stent graft system doesn’t look anything like human anatomy because it’s non-anatomical.
“It’s a construct of a metal scaffolding over the top of it,” Dr. Kelly said. “My stance has always been, ‘If I try to build a graft that looks like a person’s aorta, then I’m limited by their aorta.’”
Help more people
That design allows physicians to place it in more places that are otherwise hard to fix.
“What becomes challenging is if that dilated segment is in the segment (of an artery or vein) where there are major branches going to the arms or the legs or the kidneys. A great example of this is it’s a lot easier to fix a highway when it’s a straight segment than to fix a highway that has a major intersection,” Dr. Kelly said. “We’re not limited by people’s anatomy.”
Hence, many older people who otherwise would not qualify for open surgery may have an improved quality of life and a chance at longer life with an endovascular approach like TAAA.
“It allows us to fix the same type of aneurysm through a couple little poke-holes in the groin and a little incision in the arm,” Dr. Kelly said. “Which means, we have the potential to expand it from only being able to treat people 65, 70 years old to offering it to patients that are in their 70s and 80s that maybe have some other medical problems.”
‘Knows what he’s doing’
That was the case for Barb Hillestad, 77, of Sioux Falls. While seeking treatment for a bad hip, an X-ray revealed two large aneurysms on her upper and lower aorta. The physician she saw initially said she would need to be treated out of state. When the 2020 pandemic hit and that wasn’t an option, she looked for a specialist in town who did the surgery she required, found Dr. Kelly and got right in.
“I use a telephone book. I don’t Google everything,” Hillestad said. “And he said he had a new technique that instead of doing a big incision, which I wouldn’t pull through, ‘cause I had two of them, upper and lower on my aorta. And he said his technique would be so much better for me.
“So I said well, not much else I could do. I mean, they were getting big. I didn’t know I had them. But they had to be done right away. My hip is still bad, but the surgery really went good. Thank goodness I could have it done here.”
Hillestad said she had no complications or pain.
“He knows what he’s doing,” she said of Dr. Kelly.
Dr. Kelly has continued to evolve the device over the years, including developing the second-generation version called the Unitary device. This device is intended for aneurysms that extend up to the branch arteries but don’t fully extend into the chest. It covers less of the aorta and hopefully will reduce the risk of devastating complications such as paraplegia. The Unitary device is currently offered only at Sanford Health as part of the PS-IDE.
Early results from the first 150 patients are promising, Pohlson said.
“We want to know how this impacts other people that we may not see in South Dakota,” she said.
“We are broadening the number of patients involved and providing access to patients across the country. It’s difficult for people that are a little bit older. They may be in poor health, so for them to travel to South Dakota doesn’t really make sense. We’re also expanding the number of users. It’s important to understand how this device works in Dr. Kelly’s hands as the inventor but also in other experienced users’. Is it something that’s reproducible? That’s part of research, is figuring out, ‘Can you reproduce it and get reliable results?’”
The FDA breakthrough device designation will help.
“The significance for Sanford Health is our expertise in helping de-risk these technologies and bringing them forward to help benefit the public. We’re taking good care of our patients but we’re also developing technologies that help people being treated at other health care organizations,” Pohlson said.
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