Small, Implantable Heart Monitor May Provide More Accurate Diagnosis of Fainting Causes and Reduce Healthcare Costs.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Aug. 6, 2003

Unexplained fainting affects 1 million Americans annually

at a cost of $1 billion

The use of a small, implantable monitor in patients who experience episodes of unexplained fainting (syncope) can lead to a diagnosis at a lower cost than conventional testing strategies, according to a study published in this week's issue of Journal of the American College of Cardiology. Unexplained fainting affects more than 1 million Americans each year, is the cause of approximately 10 percent of falls by elderly persons and costs the U.S. healthcare system more than $1 billion annually.

"People who suffer from mysterious fainting episodes often live in fear, and the time and testing efforts by physicians to help identify a diagnosis consume considerable healthcare resources," said Andrew Krahn, M.D., the study's principal investigator and associate professor in the Division of Cardiology at the University of Western Ontario. "Our research shows that the Medtronic Reveal(R) Insertable Loop Recorder is both a cost-effective and quality diagnostic tool for many patients."

To evaluate the benefits of the implantable monitor, investigators at the University of Western Ontario conducted a randomized clinical trial in 60 patients who were undergoing cardiac testing for unexplained fainting. Of the patients who received the Reveal monitor, 47 percent were successfully diagnosed, while only 20 percent who received conventional testing were accurately diagnosed. In new cost-effectiveness data published today, the cost-per-diagnosis in those who were randomized to receive one year of monitoring with the Medtronic Reveal monitor was 30 percent less than the cost-per-diagnosis in those who received conventional testing. Conventional testing included two to four weeks of monitoring with an external loop recorder followed by tilt table and invasive electrophysiologic testing.

The study authors concluded that the Reveal Insertable Loop Recorder (ILR) should be considered as an early-stage diagnostic tool for people without major structural heart disease who experience unexplained fainting spells. "We've already seen evidence that the insertable loop recorder is an effective tool for identifying why many people have syncopal episodes," said Krahn. "Now, we also have demonstrated a substantial cost savings related to use of the small implanted monitor compared to conventional diagnostic strategies that are often inconclusive."

In another study about the diagnosis of syncope published in The New England Journal of Medicine in September 2002, researchers found that 10 percent of study participants with cardiac syncope would have died in six months without proper diagnosis and treatment for their cardiac condition.

The second-generation Medtronic Reveal(R) Plus is the world's only implantable cardiac monitor available to record the heart's rate and rhythm at the time of an unexplained syncopal episode. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor performs a function similar to that of a "black box" on an airplane, recording important data that can be saved and evaluated later to determine a diagnosis. It continuously monitors and can record the heart's electrical activity for up to 14 months. The Reveal Plus ILR may help diagnose whether symptoms like fainting, dizziness, palpitations and unexplained seizure-like episodes have a cardiovascular cause, or if the patient should be referred to another specialist, such as a neurologist.

"The insertable loop recorder provides a unique and cost-effective way for physicians to address the major challenge of diagnosing patients with unexplained fainting," said Warren Watson, vice president of Medtronic's Arrhythmia Management group. "This study provides further evidence of the value of implantable monitoring systems for physicians, their patients and the healthcare system."

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com. For more information about the Reveal Plus ILR, visit www.fainting.com or www.seizuresandfainting.com.

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 25, 2003. Actual results may differ materially from anticipated results.