Stents

U.S. FDA gives conditional approval letter for Powerlink system

Published in Medical Letter on the CDC and FDA, December 5th, 2004

Endologix, Inc., (ELGX) announced the receipt of a conditional approval letter from the U.S. Food and Drug Administration (FDA), allowing the commercial distribution of the company's Powerlink System, an endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA).

The conditions of approval require the standard continued postmarketing surveillance and annual update reports to the FDA and physician users.

"This is an eventful day for people with AAA and their physicians, as well as for the employees and shareholders of Endologix," said Paul McCormick, president and chief executive officer. "Use of ELGs...

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Source: Medical Letter on the CDC and FDA (2004-12-05)

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