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This article was originally published in The Gray Sheet
Firm files a PMA application for its Formula balloon expandable stent for renal artery disease and expects approval next year. Announced Sept. 24, the submission includes data from the 100-patient REFORM clinical trial, which completed enrollment in June 2009 (1"The Gray Sheet" June 18, 2009). The device features a low-profile design and does not shorten upon expansion, the company claims
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