Gore receives CE mark for lower profile Viabahn VBX endoprosthesis

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Gore has announced recent CE mark of a lower profile Viabahn VBX balloon expandable endoprosthesis (VBX stent graft).

Medical Device Regulation (MDR) approval of this innovation builds on a proven device which has become an important tool for treating complex vascular disease, the company says in a press release. In addition to offering the longest balloon expandable stent on the market with its 79mm configuration, and the widest range of stent diameter adjustability, the VBX stent graft now also offers the most 6 Fr compatible configurations, the press release adds.

“We are thankful to Gore for being able to be one of the first implanters of the new lower profile VBX stent graft in Europe,” said Michele Antonello, director of the School of Specialization in Vascular Surgery of the University of Padua (Padua, Italy). “Combined with the device flexibility, its accuracy and trusted performance, the new lower profile will enable me to treat my complex cases with a 6 or 7 Fr device.”

No changes to the stent graft design were made to achieve the lower profile. By focusing on improvements to the delivery system only, the characteristics and performance of the stent graft itself remain unchanged and are joined by the enhanced versatility a lower profile provides, Gore states. 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 data and being part of the current Gore VBX FORWARD clinical study that aims to investigate the superiority of the VBX stent graft compared with bare metal stents for the treatment of complex iliac occlusive disease, this lower profile innovation provides yet another reason to feel confident in the proven outcomes of the VBX Stent Graft and the broad applicability of its use in my practice,” said Ash Patel, vascular surgeon, Guy’s & St Thomas’ Hospital NHS Foundation Trust, London, UK.

Since its US launch in 2017, more than 500,000 VBX stent grafts have been implanted worldwide. The VBX stent graft is indicated in the EU for the treatment of: De novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation; De novo or restenotic lesions in the visceral arteries; Isolated visceral, iliac and subclavian artery aneurysms; or Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral and pulmonary arteries).

The lower profile device will be rolled out to the European market over the coming months.

“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, leader of Gore’s peripheral business. “We look forward to supporting our physicians and their patients through the delivery of this exciting innovation to their treatment toolbox.”

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