FDA keurt eerste stent met ballon voor heupslagader goed
FLAGSTAFF, Ariz.–(BUSINESS WIRE)– W. L. Gore & Associates (Gore) heeft bekendgemaakt dat zijn GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) door de Amerikaanse FDA is goedgekeurd voor de behandeling van een de novo laesie of een laesie door restenose in de heupslagader, inclusief beschadigingen aan de bifurcatie van de aorta. Daarmee is dit de enige beschikbare stentgraft met ballon met indicatie voor de heupslagader.
“De VBX Stent Graft was bleek direct en na negen maanden veilig en effectief bij de behandeling van vernauwingen in de heupslagader, wat kan worden toegeschreven aan het uitzonderlijke ontwerp van het medische middel”, zei medicus Jean Bismuth. Hij vervolgde: “Over het geheel genomen, zijn meerdere klinische baten waargenomen. Zo was er geen verandering aan het mediaan van de lengte van de stent bij het inbrengen, een technisch slagingspercentage van 100 procent en waren er geen complicaties met losgeraakte stents of noemenswaardige gevallen van reststenose. Het onderzochte hulpmiddel presteerde goed in problematische laesies, inclusief vernauwing. Dit pleit voor zijn traceerbaarheid, radiale kracht, aanpasbaarheid en behoud.”
FDA Approves First Balloon Expandable Stent Graft for Use in the Iliac Artery |
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FLAGSTAFF, Ariz.–(BUSINESS WIRE)– W. L. Gore & Associates (Gore) has announced that the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170130005288/en/  FDA approval of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis marks the availability of the only balloon expandable stent graft with an indication for the iliac artery. (Photo: Business Wire)
“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 Jean Bismuth, MD. Dr. Bismuth continued, “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.” Gore VBX FLEX IDE Clinical Study Of the patients in the Gore VBX FLEX IDE clinical study (n=134), 32 percent 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:
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. AVAILABILITY “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. 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. Gore provides a portfolio of peripheral vascular solutions that are 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. For more information, visit goremedical.com/vbx ABOUT W. L. GORE & ASSOCIATES At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984. Products listed may not be available in all markets. GORE®, VBX, and VIABAHN® are trademarks of W. L. Gore & Associates. View source version on businesswire.com: http://www.businesswire.com/news/home/20170130005288/en/ Contacts Bliss Integrated Communication for Gore Medical |
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