With improvements to the stent graft delivery system enabling a 1 Fr profile reduction on the majority of sizes, the device now offers the most 6 Fr compatible configurations among balloon expandable stent grafts.FLAGSTAFF, Ariz., Jan. 31, 2024 /PRNewswire/ -- As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W.

随着对支架-移植物输送系统的改进，使大多数尺寸的1 Fr轮廓减小，该设备现在提供了球囊扩张支架移植物中最多6 Fr兼容的配置。亚利桑那州弗拉格斯塔夫（FLAGSTAFF），2024年1月31日/PRNewswire/——作为不断改进复杂血管疾病患者医疗解决方案的努力的一部分，W。

L. Gore & Associates, Inc. (Gore) announced recent FDA approval of a lower profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft)..

五十、 Gore＆Associates，Inc.（Gore）最近宣布FDA批准了一种低调的Gore®VIABAHN®VBX球囊可扩张内假体（VBX支架移植物）。。

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GORE(R) VIABAHN(R) VBX Balloon Expandable Endoprosthesis

戈尔（R）维亚巴恩（R）VBX球囊扩张内假体

FDA approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease. In addition to offering the longest balloon expandable stent on the market with its 79 mm configuration, and the widest range of stent diameter adjustability, the VBX Stent Graft now also offers the most 6 Fr compatible configurations among balloon expandable stent grafts.

FDA对这项创新的批准建立在一种经过验证的设备上，该设备已成为治疗复杂血管疾病的重要工具。除了以79毫米的配置提供市场上最长的球囊扩张支架和最广泛的支架直径可调节性外，VBX支架移植物现在还提供了球囊扩张支架移植物中最兼容6 Fr的配置。

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'Our team is pleased to be the first commercial implanter of the new lower profile VBX Stent Graft,' said Darren Schneider, M.D., Chief of Vascular Surgery and Endovascular Therapy, Penn Medicine, Philadelphia, Pennsylvania. '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.'.

宾夕法尼亚州费城宾夕法尼亚州医学院血管外科和血管内治疗主任达伦·施奈德（DarrenSchneider）医学博士说，我们的团队很高兴成为第一个商业植入新型低轮廓VBX支架移植物的人结合我一直信任的该设备的灵活性，强度和部署准确性，新的较低配置将使我能够使用6或7 Fr设备治疗大多数复杂病例，降低进入并发症的风险，同时为更多患者带来可信的VBX支架移植物结果。”。

No changes to the stent design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the valued characteristics and trusted performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides. Depending on the practice, physicians may be able to use the VBX Stent Graft with a broader set of patients, experience a lower risk of complications at the access site, find improved procedure efficiency and/or a general improvement in ease of use.'With the recently published five-year outcomes data, and the active pursuit of evaluating superiority versus bare metal stents in complex iliac occlusive disease through the Gore VBX FORWARD Clinical Study (NCT05811364), this lower profile innovation gives me yet another reason to feel confident in the proven outcomes and broad versatility of this device in my practice,' said Ehrin Armstrong, M.D., Interventional Cardiologist and Director of Clinical Research, Advanced Heart and Vein Center, Denver, Colorado.Since its U.S.

没有改变支架设计以实现较低的轮廓。通过仅关注输送系统的改进，支架移植物本身的宝贵特性和可靠性能保持不变，并通过较低配置提供的增强的多功能性而结合在一起。根据实践，医生可能能够在更广泛的患者中使用VBX支架移植物，降低进入部位并发症的风险，提高手术效率和/或普遍改善易用性。”埃林·阿姆斯特朗（Ehrin Armstrong）说，根据最近公布的五年结果数据，以及通过戈尔VBX前瞻性临床研究（NCT05811364）积极寻求评估复杂髂骨闭塞性疾病相对于裸金属支架的优越性，这一低调的创新为我提供了另一个理由，让我有信心在我的实践中证明这种设备的效果和广泛的多功能性，医学博士，介入心脏病专家，科罗拉多州丹佛高级心脏和静脉中心临床研究主任。自其美国。

launch in 2017, more than 375,000 VBX Stent Grafts have been implanted worldwide.* Currently in the U.S., the device is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5-13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.The lower profile device will be rolled out to the U.S.

2017年推出，全球已植入375000多个VBX支架移植物。*目前在美国，该装置适用于治疗髂动脉中发现的新生或再狭窄病变，参考血管直径范围为5-13毫米，病变长度高达110毫米，包括主动脉分叉处的病变。这种低调的设备将在美国推出。

market over the coming months and is also being studied in the Type IV Thoracoabdominal Aortic Aneurysms (TAMBE) Trial (NCT02528500).'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 .

未来几个月的市场，也正在IV型胸腹主动脉瘤（TAMBE）试验（NCT02528500）中进行研究较低规格VBX支架移植物的批准和发布证明了戈尔医疗产品部门致力于持续改进和终身创新。