Hypertension

CVRx receives approval for Rheos Baroreflex Hypertension Therapy System trial

Published in Health Business Week, November 17th, 2006

CVRx, Inc., a private medical device company that has developed an implantable medical device to treat high blood pressure, has received a conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a U.S. pivotal clinical trial that will evaluate the safety and effectiveness of the Rheos Baroreflex Hypertension Therapy System.

Data from this clinical trial is intended to support the Pre-Market Approval (PMA) application for the Rheos System to the FDA.

"The Rheos System represents a fundamentally new approach to therapeutic intervention for resistant hypertension," said the clinical trial's...

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Source: Health Business Week (2006-11-17)

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