Fusion Medical Technologies
This article was originally published in The Gray Sheet
Executive SummaryFiles last module of a modular premarket approval application for the FloSeal matrix hemostatic sealant Feb. 23, which includes a final report on its 309-patient, 10 site pivotal U.S. clinical trial for the device for use in cardiac, vascular and spinal surgery. Results showed a 96% success rate for the sealant in stopping bleeding within ten minutes of application ("The Gray Sheet" Dec. 14, 1998, p. 16). Fusion expects to introduce the FloSeal onto the U.S. market by early 2000
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