FDA approves low-profile balloon expandable stent
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Key takeaways:
- The FDA approved a new low-profile balloon-expandable stent.
- The stent is compatible with 6-French sheaths with its modified delivery system.
W. L. Gore and Associates announced the FDA approved of its low-profile balloon expandable stent for treatment of iliac artery de novo or restenotic lesions with reference vessel diameters of 5 to 13 mm and lesion length up to 110 mm.
With a 1-French profile reduction for many sizes, the stent graft (Gore Viabahn VBX) is designed with the most 6-French-compatible configurations among balloon-expandable stents and may be used in an expanded set of patients, according to a press release from the company.
"With the recently published 5-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, 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," Ehrin Armstrong, MD, interventional cardiologist and director of clinical research at the Advanced Heart and Vein Center in Denver, said in the release.
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