Endologix PowerLink
This article was originally published in The Gray Sheet
Executive Summary
First two modules of a PMA for less-invasive abdominal aortic aneurysm treatment system are submitted to FDA May 15. Included are manufacturing, quality systems and animal study data. Completion of the PMA, with 12-month follow up on 193 patients, is expected in the third quarter...
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Endologix
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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