New Study Shows Early Diagnosis and Treatment Strategy Using Medtronic Implantable Heart Monitor Reduces Recurrence of Fainting.

STOCKHOLM, Sweden -- The use of an integrated diagnosis and treatment strategy for certain patients who experience episodes of suspected neurally mediated syncope (fainting) leads to a major reduction in the recurrence of syncope, according to a study presented today in a Hot Line session at the European Society of Cardiology (ESC) Congress 2005 in Stockholm, Sweden. Investigators in the International Study on Syncope of Uncertain Etiology 2 (ISSUE2) trial used a new risk stratification and treatment strategy to identify which patients with neurally mediated syncope can benefit most from an implantable device and experience a reduction in fainting episodes. The strategy includes a simple initial evaluation, early use of the Medtronic Reveal(R) Plus insertable loop recorder (ILR), assessment of the exact mechanism of syncope and prescription of a mechanism-based therapy.

"Living with mysterious fainting episodes can cause great fear in patients and exposes them to the risk of significant trauma. Prior to this study, treatment of neurally mediated syncope has been typically guided by the results of inconclusive tilt testing, and the use of pacing therapy without a better upfront diagnosis has not been proven to be effective in many of these patients," said Dr. Michele Brignole, Department of Cardiology, Ospedali del Tigullio, Lavagna, Italy, and primary investigator for ISSUE2. "This new research demonstrates that improved patient selection with the Medtronic Reveal Plus ILR and targeted device therapy leads to a significant reduction in episodes of fainting. This is a major step forward in the treatment of unexplained fainting."

ISSUE2 was a multi-center, prospective, observational study enrolling 442 patients from 63 centers across Europe and in the United States with a diagnosis of suspected neurally-mediated syncope. The patients had experienced three or more clinically severe syncopal episodes over two years, without significant electrocardiographic and cardiac abnormalities. In phase I, all patients were implanted with a Reveal Plus ILR and followed until the first documented syncopal episode. The mechanism of this episode was documented by the ILR in 103 patients (mean time of 12 +/- 8 months) and guided subsequent therapy. Forty-seven patients received a pacemaker due to asystole (median 11.5 seconds in duration); 6 patients were treated with anti-tachyarrhythmia therapy (catheter ablation, implantable cardioverter-defibrillator or antiarrhythmic drugs); and the remaining 50 patients had normal sinus rhythm and did not receive specific therapy.

Results

In phase II, the 103 patients with documented events entered an observational period to determine syncope recurrence. The 1-year syncope recurrence rate in the 53 patients who received pacemaker or anti-tachyarrhythmia therapy was 10 percent, compared to a 41 percent recurrence rate in the 50 patients who did not receive therapy. This equates to an 80 percent relative reduction in the risk for syncope recurrence at one year for those who received ILR-guided therapy. In addition, the 1-year syncope recurrence rate in the 47 patients who received a pacemaker was five percent.

The Medtronic Reveal Plus ILR is the world's only implantable cardiac monitor that records 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 evaluated later to determine a diagnosis. It continuously monitors the heart's electrical activity and can record heart rhythm episodes 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. More than 60,000 Medtronic ILRs have been implanted since they were first introduced. For more information about the Reveal Plus ILR, visit www.fainting.com or www.seizuresandfainting.com.

Studies have shown that about 40 percent of the general population will experience at least one episode of syncope in their lifetime.

"The ISSUE2 study offers tremendous insight for physicians seeking to treat fainting patients more easily and effectively. It provides strong evidence that the Medtronic insertable loop recorder and, when appropriate, the resulting use of a pacemaker or defibrillator can provide an effective set of tools in the diagnosis and treatment of unexplained fainting," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "We expect more physicians to consider the ILR as an important early risk stratification tool for many patients who experience unexplained fainting."

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results.