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Scott & White News Release

Judy Curtis
Manager, Media and Public Relations
254-724-4097
Pager: 254-762-0236

FOR IMMEDIATE RELEASE
November 21, 2007


Scott & White implants device to control blood pressure

– FDA Clinical trial aims to prove effectiveness of new drug-free treatment –

TEMPLE, Texas - (Nov. 21, 2007) Scott & White on Tuesday became the first hospital in Texas to implant an experimental medical device designed to treat uncontrolled high blood pressure.

About 20 million people in the U.S. suffer from uncontrolled, drug-resistant high blood pressure. High blood pressure can result in heart disease, stroke and death.

In an FDA-approved clinical trial, Scott & White Vascular surgeons and study investigators Dr. Robert Feldtman and Dr. Todd Bohannon implanted the CVRx Rheos Baroreflex Hypertension Therapy system in two subjects whose high blood pressure has been unresponsive to medication.

"This is very exciting technology," said Dr. Feldtman. "This is equal to the breakthrough in the 1950s when the first heart pacemakers were implanted in heart patients."

The clinical trial aims to determine whether the Rheos system is a safe and effective treatment for subjects with high blood pressure that cannot be controlled with medication and lifestyle changes.

This investigational therapy takes advantage of the body's own natural blood pressure regulation system (baroreflex) to control blood pressure and improve cardiovascular function.

The Rheos' battery-operated generator, about the size of an IPOD, is implanted under the skin near the collarbone. Two electric leads are inserted on both sides of the neck to transmit information to the brain. After the Rheos system activates the body's blood pressure regulators, the brain acts to lower blood pressure by sending signals to various parts of the body.

"Our hope is that the device will decrease medication requirements, since many of the blood pressure medications can carry significant side effects," said Dr. Bohannon. "The purpose of this investigational trial is to see how much the medications can be reduced."

The Rheos system is an investigational therapy and is currently under evaluation in a pivotal trial to determine if it is safe and effective. While some 80 devices have been implanted in subjects worldwide, this pivotal trial will allow for several hundred subjects to be evaluated in the U.S. as well to help researchers further understand the device's efficacy.

The FDA requires studies before a new agent or device is made available to the public to be conducted in approved medical centers. Scott & White is the only approved study center in Texas.

Scott & White is currently screening subjects to establish their eligibility for participating in the trial study. Clinical Research Coordinator for this study is Karla Coco, R.N., Vascular Surgery Division.  You can get more information by calling 1-866-685-2628, or go online to www.rheosstudy.com.


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