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This article was originally published in The Gray Sheet

Executive Summary

FDA approval for PowerLink endoluminal stent graft is expected by the second half, the firm says. Completion of the modular pre-market approval process and 259-patient pivotal clinical trial was announced Jan. 8. Preliminary results from an earlier, 154-patient, one-year study showed that the PowerLink minimally-invasive abdominal aortic aneurysm treatment system was safely deployed 98% of the time. The company announced submission of the first two PMA modules in May (1"The Gray Sheet" May 19, 2003, In Brief)...

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