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Gore enrolls 1st patient in its REVISE clinical study.(Clinical report)
Gore enrolls 1st patient in its REVISE clinical study
By OMAR FORD
Medical Device Daily Staff Writer
Nearly 300 patients are subject to take part in the W.L. Gore (Flagstaff, Arizona) REVISE clinical study, which started earlier this month.
According to the company, the study is a randomized, multi-center trial used to establish the efficacy and safety of the Gore Viabahn Endoprosthesis with Propaten Bioactive Surface to revise arteriovenous (AV) grafts at the venous anastomosis in hemodialysis patients.
The study randomizes patients to the Gore Viabahn Endoprosthesis with Propaten Bioactive Surface and to percutaneous transluminal angioplasty (PTA). The study is expected to have up to 280 subjects, with 140 subjects in each treatment arm spread out over 30 sites. It is slated to be completed in 2012.
"This study will provide the clinical community with valuable data on the performance of this heparin-bonded stent graft for AV graft revisions, rather than PTA alone," said Andrew Nish, MD. "The study is designed to show any difference in time between interventions when using stent grafts to treat venous outflow stenoses."
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...including the GORE PROPATEN Vascular Graft and GORE VIABAHN([R]) Endoprosthesis. The data was recently...release details of an interim report about the GORE VIABAHN Endoprosthesis from a study for the management of superficial...
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- Press release article from: Business Wire January 12, 2009 700+ words
...commercial distribution of its GORE VIABAHN Endoprosthesis with PROPATEN Bioactive...European Union. The GORE VIABAHN Endoprosthesis with PROPATEN Bioactive...proven performance of the GORE VIABAHN Endoprosthesis for the treatment of...
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- Press release article from: Business Wire February 25, 2008 700+ words
...with adjunct PTA and GORE VIABAHN Endoprosthesis with Heparin Bioactive...popliteal arteries. The GORE VIABAHN Endoprosthesis with Heparin Bioactive...surface treatment with the GORE VIABAHN Endoprosthesis. The excellent flexibility...
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- Press release article from: Business Wire October 17, 2005 700+ words
...said Ansel. The GORE VIABAHN Endoprosthesis is constructed with a...centimeters or longer with the GORE VIABAHN Endoprosthesis compared to bare Nitinol...randomized to either the GORE VIABAHN Endoprosthesis or bare Nitinol stent...
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- Press release article from: Business Wire September 17, 2008 700+ words
...FDA) to market the GORE VIABAHN Endoprosthesis for use in patients with...0 - 12.0 mm. The GORE VIABAHN Endoprosthesis was previously approved...its indication for the GORE VIABAHN Endoprosthesis to the iliac arteries...
Source: HighBeam Research, Gore enrolls 1st patient in its REVISE clinical study.(Clinical...