Bravo pH Monitoring System from Medtronic Improves Quality of Acid Reflux Testing.

Business Editors/Health/Medical Writers

ORLANDO, Fla.--(BUSINESS WIRE)--May 21, 2003

Catheter-free technique offers multiple benefits to

GERD patients and their doctors, studies find

For years, physicians have used nasal catheters to measure esophageal acid levels with pH testing in patients suspected of having acid reflux, or gastroesophageal reflux disease (GERD). But patients often find the traditional technique to be uncomfortable and inhibiting, only tolerating the catheter for 24 hours.

According to the results of several studies presented to gastroenterologists participating in Digestive Disease Week (DDW), a catheter-free technique called the Bravo(TM) pH Monitoring System from Medtronic, Inc. (NYSE:MDT), improves the quality of acid reflux testing. The Bravo System provides a more comfortable alternative to the nasal catheter that allows patients to engage in their normal daily activities. It also provides more data that is more representative of esophageal acid exposure than the traditional technique.

"Because patients can tolerate pH testing with the Bravo System much better than the traditional technique, we are able to extend the recording interval of the pH test by an additional 24 hours," said Dr. Edward Lin, assistant professor of surgery at the Emory University School of Medicine's Endosurgery Unit in Atlanta, and the lead author of one of the studies. "This provides patients and physicians with more of the information that is necessary to make an accurate diagnosis."

According to the International Foundation for Functional Gastrointestinal Disorders (IFFGD), GERD affects an estimated 21 million Americans and is most commonly characterized by frequent, chronic heartburn. Untreated, it can lead to inflammation and injury of the esophagus or a potentially pre-cancerous condition called Barrett's esophagus. As noted by the American Gastroenterological Association (AGA) during a study conducted in 2001, direct and indirect costs associated with treating GERD total $10 billion per year in the United States alone.

Dr. Lin's study -- the largest of the Bravo System to date, with 245 patients undergoing evaluation for GERD over a two-year period -- found that 48-hour testing with the catheter-free Bravo System detects more abnormalities than a 24-hour test using the same method.

During the first 24 hours of testing, the researchers recorded 99 abnormal pH studies. During the second 24-hour period, they recorded an additional 24 (10 percent) abnormal pH studies. These findings confirm that the Bravo pH Monitoring System provides more representative data of a patient's typical day, which may allow for a more accurate diagnosis.

Several other studies presented at DDW further emphasized the benefits of the Bravo pH Monitoring System:

-- Researchers from the Mayo Clinic in Jacksonville, Fla., noted

their experience with the technique, concluding that pH

testing using the catheter-free system enhances patient

convenience and comfort.

-- In a direct comparison to nasal catheters, researchers from

the University of Southern California (USC) found that pH

testing with the Bravo System detects greater percent total

time with an acidic reading (pH less than 4) and a higher

number of reflux episodes.

Delivered and placed following endoscopy, the Bravo System consists of a capsule (about the size of a gelcap) that is temporarily attached to the esophageal wall and transmits pH data through radiotelemetry to a pager-sized receiver worn by the patient. After the 48-hour testing period with the Bravo System, the patient's data is downloaded from the receiver to a computer with Medtronic POLYGRAM(TM) NET pH analysis software. Within 7-10 days of being attached, the Bravo capsule spontaneously detaches and passes through the digestive tract.

The Bravo System is just one component of the Medtronic suite of technologies for the diagnosis and treatment of gastrointestinal conditions. Medtronic Gastroenterology also offers Enterra(TM) Therapy for the treatment of gastroparesis, and is the world leader in gastrointestinal function testing equipment.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.

EDITOR'S NOTE: Fact sheets on GERD and the Bravo pH Monitoring System can be found at http://www.medtronic.com/newsroom/ media_kits_GastrointestinalConditions.html (Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field.)