FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. Additionally, the company says VBX now offers the most 6 Fr-compatible configurations among balloon-expandable stent grafts.
Dr. Darren Schneider and his team at Penn Medicine completed the first commercial implant of the new system.
“Combined with the flexibility, strength and deployment accuracy I’ve always trusted with the device, the new lower profile will enable me to treat most of my complex cases with a 6 or 7 Fr device, reducing the risk of access complications while bringing trusted VBX stent graft outcomes to more of my patients,” Schneider said in a news release.
More about the updated Gore stent graft
Gore made no changes to the stent design to achieve the lower-profile version. The company focused solely on improvements to the delivery system. Physicians may now have the option to use the stent graft with a broader set of patients. They may also experience a lower risk of access site complications, find improved efficiency and an improvement in ease of use.
The device currently has an indication for treating de novo or restenotic lesions found in the iliac arteries. These lesions have reference vessel diameters ranging from 5-13 mm and lesion lengths up to 110 mm. This includes lesions at the aortic bifurcation.
Gore plans to begin rolling out the lower-profile device in the U.S. in the coming months. It also has a study underway evaluating it in type IV thoracoabdominal aortic aneurysms.
“The approval and release of the lower profile VBX stent graft serves as a demonstration of the Gore Medical Products Division’s commitment to continual improvement and lifelong innovation in collaboration with physicians to solve tough challenges where there is a critical patient need,” said Jill Paine, peripheral business leader for Gore’s Medical Products Division. “We look forward to supporting our physicians and their patients through the delivery of this exciting innovation to their treatment toolbox.”