St. Jude Medical, Inc.

U.S. FDA grants approval of IDE to begin enrollment in ESCAPE migraine study

Published in Drug Law Weekly, September 20th, 2005

St. Jude Medical, Inc. (STJ) announced that it has received conditional approval from the U.S. Food and Drug Administration of an Investigational Device Exemption (IDE) to begin enrollment in the ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) migraine trial.

St. Jude Medical has received FDA conditional approval to study the potential connection between patent foramen ovale (PFO) closure and migraine headaches. A PFO is a structural defect of the heart where a small hole between the right and left atria (upper chambers of the heart) fails to close in infancy. An estimated 25% of the adult population has a PFO but in most people it is...

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Source: Drug Law Weekly (2005-09-20)

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