Earlier this year, Gore Medical celebrated a landmark anniversary. The first in-human implant of the GORE EXCLUDER AAA Endoprosthesis took place in September, 1997. Now a healthcare industry standard in the treatment of vascular disease, the device sometimes had a tough path to adoption.
In the end, it was partnerships with physicians that made all the difference.
To learn more, Surgical Products interviewed Eric Zacharias, vascular business leader at Gore Medical.
What can you tell us about the anniversary of the GORE EXCLUDER AAA Endoprosthesis?
Gore has a long history of innovation in developing prosthetic vascular grafts to treat vascular disease. In the 1990s, Gore partnered with a small startup called Prograft that brought stent technology for endovascular platforms. In that partnership, Gore brought material expertise of ePTFE grafts and films, and together with ProGraft developed a platform of stent grafts that has been leveraged for more than 20 years now.
We’re upon the 20-year anniversary of use of the GORE EXCLUDER in implants as a minimally invasive alternative to the open repair of aortic aneurysms.
What were the initial reactions to the GORE EXCLUDER Device?
Gore was in the second tier of companies delivering minimally invasive solutions to aortic aneurysm treatment. There were a handful of companies moving ahead of us, but we were still on that early cusp when we partnered with Prograft to develop the GORE EXCLUDER Device. There were early physician adopters that were quick to move the space forward. As is always the case, the bulk of the community was more skeptical of the move away from surgical solutions.
There were established surgical treatments for aortic aneurysms that carried a reasonable and good clinical outcome, but were also quite invasive to the patient. Finding an equivalent method to treat that disease with a minimally invasive approach had its resistance early on. It took time to break that resistance down and use sound research to really convey to that broader base of physicians that endovascular repair was a reasonable means of treating patients.
The field evolved as device and technology advancements overcame deficiencies in early platforms and the clinical understanding grew. Today, we have a robust solution for patients that’s proven with long-term clinical evidence.
(Image credit: Gore Medical)
What approach did Gore take in evolving the tools and solutions in this area?
Innovation broadly comes from the physicians. They have an understanding of what it actually takes to treat patients effectively. It makes the medical technology space a really dynamic area where you need to have these complex partnerships between companies and the physicians who treat patients and see the challenges and limitations.
Physicians see how these procedures impact patients, but they don’t necessarily have the tools, the investment, or the support base in many cases to leverage that information into solutions. Obviously, there are a lot of physician-inventors, physicians that have their ideas and go and start companies. But many physicians want to spend their time treating patients. Their ability to partner with companies — provide ideas about how things can evolve and get better — really serves as the backbone of continuing to evolve and advance therapies.
In the case of Gore, we had physician partnerships and made sure we had good clinical oversight on device performance. In early GORE EXCLUDER Device use, we started to see low rates of aneurysm sac expansion. As far as you could tell from the imaging, the aneurysm had been excluded, which is the goal of the therapy. The imaging didn’t show any indications of blood leaking around the device. But we also saw indications of the aneurysm sac continuing to enlarge.
It took us time to investigate it and understand the cause, but it was really the partnership with physicians that was helping us see that the clinical incidence was real. It led to the understanding that we had a preferential permeability issue with our original construct of the device.
Through our physician partnerships, we were able to identify a relatively straightforward solution where we added a new, very thin layer of film into the graft construct. It was able to stop that permeability. What made it subtle was that the permeability was in a low rate, so only a few patients had those complex interactions, but we were able to work with physicians to identify and make that change to the device that is present in our designs to date.
That was one example and we’ve continued to have similar advancements with our devices over time to build a portfolio of products we think continues to advance the ability to minimally invasively treat the disease.
Has the level of physician feedback changed over the years?
When many manufacturers first got into the endovascular treatment of aneurysms, the view was we would train physicians how to use these products and then they would perform the procedures without assistance. As the space developed, that partnership between physicians and companies was not just on the product design iterations, but it was also on factors like which patients best fit the device, how do we make decisions on sizing, how do we best make decisions on various nuance of the anatomy? The clinical case support that developed has become an important component that’s really valued by physicians.
So after 20 years with the GORE EXCLUDER Device, what does the field look like now?
Over many years of research, there’s been continuing advancement of the ability to understand clinically how these devices perform. When we look at follow-ups on the order of five years, surgical outcomes and endovascular outcomes are generally seen as equal. There’s a better understanding of the cost implications of these therapies and making sure there’s a continuing advancement in the ability to provide these therapies at a reduced cost.
The treatment of aneurysms continues to advance towards minimally invasive solutions with a continued focus on making sure we have data to support long-term outcomes. It’s part of what’s represented in our 20 years of experience with GORE EXCLUDER Device. We have things like the Global Registry for Endovascular Aortic Treatment (GREAT), where we have 5,000 patients worldwide. We’ll track those patients for 10 years.
The big shift right now is on more complex disease. Treating complex disease with endovascular tools is the next frontier. It’s been underway for at least 10 years, and we’re continuing to advance technologies that allow patients with disease that involves more complex areas of the anatomy to benefit from endovascular therapy and providing data to prove that.
