Drug Development

Low-profile optional vena cava filter receives conditional approval to begin clinical trial

Published in Medical Letter on the CDC and FDA, December 10th, 2006

Rex Medical has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a U.S. clinical trial for the Option Retrievable Vena Cava Filter in the prevention of recurrent pulmonary embolism (PE).

This prospective, multicenter study is designed to collect clinical data and establish the safety and efficacy of the Option Filter in support of both a permanent and retrieval indication. Ten U.S. sites have been selected to participate in this study. Matthew S. Johnson, MD, associate professor of Radiology, Indiana School of Medicine and Chief, Vascular and Interventional Radiology, Clarian Health Partners will be the lead...

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Source: Medical Letter on the CDC and FDA (2006-12-10)

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