Gore’s Viabahn VBX: The very model of a modern major product launch

The Viabahn VBX built by Gore is the first and only balloon expandable stent graft with an iliac indication. It is a balloon-mounted, ePTFE-coated, stainless-steel stent. To deploy a physician accesses the artery and blows up the balloon, forcing the device to expand. The balloon provides radial strength while the stent it deployed, but also offers easy access to the vasculature.

Future medical device developers should take note. Because although this is a technology story, for Gore—and for all medical device development—it is really all about economics.

Finding open therapeutic space and pairing it with technical know-how

The iliac area requires more strength and doesn’t need as much flexibility as a stent in, say, the femoral artery, explains Ray Swinney, global business leader for interventional products at Gore. He notes that it is a logical jump for Gore to add a balloon expandable option into its Viabahn line. “We were particularly interested in this market because there’s only one other balloon expandable stent graft approved for use in the US,” Swinney says. “It’s an attractive market for us—an area where we felt that our expertise could help to enhance and add a competitor to a market that only had one entry.”

In addition to being an open therapeutic space, Swinny says a balloon expandable stent is something the healthcare industry wanted. “We spoke with physicians and customers, and providers.” In particular, care providers wanted better options to treat iliac disease. Dr. Chris LeCroy is a practicing vascular surgeon who helped Gore develop and test the Viabahn VBX product. He explains that the access to the iliac is incredibly tortuous and that options are limited: “I’ve never been able to access those places that have branches and curves.”

In particular, care providers wanted better options to treat iliac disease. Dr. Chris LeCroy is a practicing vascular surgeon who helped Gore develop and test the Viabahn VBX product. He explains that the access to the iliac is incredibly tortuous and that options are limited: “I’ve never been able to access those places that have branches and curves.”


[Video: Device animation showing the tortuous nature of the iliac artery and how the Viabahn VBX deploys.]

Other stents, which have been designed for different parts of the body, are too rigid to get to the vessel. The other challenge with other products is foreshortening (also called compression or recoil). LeCroy says that the most common problem with iliac stent placement is immediate restenosis.

Shifting the health economics unit to value and outcomes

Gore’s health economics unit recently refocused to do more data analysis. Belinda Mohr is a health economist for the company. She says that it is important the company ensure it is establishing value for its products, and in getting the Viabahn VBX on the market, her team took that directive seriously.

“Economic value is driven by performance and clinical outcome,” she says, so it makes sense that Gore would shift the economics unit toward such endeavors.

Mohr notes that her team first set out to use clinical test data to prove value. The team looked at the trial results to see how the device performed and noticed two specific things: that Viabahn VBX had zero stent dislodgements, and did not exhibit foreshortening.

When dislodgement or foreshortening occurs, she says, they are considered complications. Therefore, the fact that VBX did not have them directly translated to cost savings for the hospital. “When you have stent dislodgement, it might require an additional surgical procedure to remove the stent; then you have to have another one put it—that adds cost to the case,” Mohr says.

The same is true with foreshortening. In other surgeries, if the stent shrinks, physicians may need to add another stent to make up for the lost length. Adding another stent adds cost as well as risk. Mohr says Gore designers considered that risk and how to mitigate it. “Viabahn VBX is available in 79 mm, which is the longest length that’s available of any other balloon expandable stent graft,” she says.

Reducing such complications is of value to a patient as well as a provider. A single surgery ensures less risk of complications and quicker recovery time.

Digging through the literature

Mohr says having data to show these benefits is just good business: “There are guidelines out there as to how to prove the value of any type of medical technology, and so we make sure that we follow those guidelines, that we are honest with our work, and that our work is credible.”

Mohr explains that Gore’s trial was a single-arm study and didn’t have any comparator data. Therefore, she knew her team would have to “go digging through the literature” to see how VBX’s numbers compared with other rates. “To tell a value story and to be able to prove it, you have to make sure you understand the current baseline, as well as the value to the provider.”

Gore has calculated the potential cost savings of reduced readmissions as well as the cost reduction potential of having longer stent lengths available and use of fewer balloons. For LeCroy, the value is simple. “I can get it where I need it—it all works together.”

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