FDA Approval for First Balloon Expandable Stent Graft for Use in the Iliac Artery February 3, 2017

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W. L. Gore & Associates tells us  its GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) has received U.S. FDA approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.

Background

Gore says its portfolio of peripheral vascular solutions is designed and tested so physicians can more reliably treat patients with a wide range of challenging peripheral disease presentations and improve those patients’ outcomes. Each interventional solution is engineered for durability, accuracy, thromboresistance and conformability, and is backed by dedicated service to help improve patient outcomes.

The VBX Stent Graft was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters to cover a wide variety of treatment needs.

In the Gore VBX FLEX IDE clinical study (n=134), 32 percent of patients presented with TASC II type C or D lesions, 18 percent required contralateral access to the lesion, and 42 percent involved kissing stents at the aortic bifurcation. Clinical data from the Gore VBX FLEX IDE clinical study conducted for FDA approval reflected that the design components of the VBX Stent Graft were resilient both during stenting procedures and over time:

  • 100 percent success rate in device delivery and coverage of target lesions in all study subjects;
  • 100 percent success rate in reducing the target lesion to less than or equal to 30 percent of the original stenosis;
  • Zero change in median length of the device upon deployment; and
  • 96.9 percent primary patency at nine-months, including a 95.3 percent primary patency rate in those patients with TASC II C or D type lesions.

Further, there were no reported incidences of device dislodgement, failures in stent integrity, or device-related serious adverse events through the primary endpoint follow up, meaning no additional costs incurred for either endovascular or surgical stent removal. The VBX Stent Graft does not require pre-dilation, which reduces the number of balloons required, and the longer lengths available reduce the need to use multiple stents for extensive lesions, both of which also contribute to procedural cost savings.

Physician comments

“The VBX Stent Graft demonstrated notable immediate and nine-month safety and efficacy in treating patients with iliac occlusive disease which can be attributed to the exceptional device design, said Dr. Jean Bismuth, MD, DeBakey Heart & Vascular Center, The Methodist Hospital in Houston, Texas.

“Overall, there were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100 percent technical success rate with no occurrences of stent dislodgement or significant residual stenosis. The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability, and stent retention.”

Company comments

“The VBX Stent Graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers and physicians,” said Ray Swinney, Peripheral Interventional Business Leader at Gore.

Source: W. L . Gore & Associates


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