Study Shows Simple, Strategic Programming of Medtronic Implantable Defibrillator Reduces Shocks; Use of Optimal Shock-Reduction Features May Aid Patient Acceptance of ICD Therapy

Business Wire, May 7, 2005

NEW ORLEANS -- In people with an implantable cardioverter-defibrillator (ICD), physician use of a prescribed set of highly sophisticated ICD heart rhythm detection and therapy parameters can help reduce the proportion of fast heart rhythm episodes shocked with high-energy electrical therapy. The findings from the EMPIRIC randomized, controlled clinical trial were presented today during a Late-Breaking Clinical Trial at HEART RHYTHM 2005, the Heart Rhythm Society's 26th Annual Scientific Sessions.

EMPIRIC compared the proportion of fast heart rhythm episodes shocked using two ICD programming approaches: a strategically chosen (empiric) collection of parameters intended to optimally leverage advanced Medtronic device features; and a patient-by-patient, physician-tailored programming approach. EMPIRIC is the first ICD trial with a primary endpoint focused on the proportion of shocks for both true ventricular tachycardia (VT)/ventricular fibrillation (VF) and true supraventricular tachycardia (SVT) episodes.

The Medtronic dual-chamber ICD used in the EMPIRIC study includes advanced features designed to reduce shocks by terminating life-threatening VT/VF heart rhythm episodes with painless pacing therapy (anti-tachycardia pacing or ATP) and by accurately detecting rhythm abnormalities like SVT that do not require shock therapy. The study is one element of Medtronic's comprehensive clinical strategy targeting the reduction of ICD shocks to improve care of ICD patients.

"Because shocks are major causes of anxiousness for many ICD patients, reducing shocks while delivering effective treatment is critical to patient acceptance of ICD therapy," said Dr. Bruce L. Wilkoff, director of cardiac pacing and tachyarrythmia devices at the Cleveland Clinic Foundation and EMPIRIC primary investigator. "I expect these results will surprise many physicians, but it's important we consider this study as we implant future ICDs. Device manufacturers have developed highly sophisticated technologies that can minimize ICD shocks, and now we also have a proven, optimal programming approach to simplify therapy prescription and improve patient outcomes."

The study demonstrated that an empiric set of sophisticated shock-reduction features is equally effective as customized physician programming for minimizing patient shocks. More specific study results include:

--In the empiric arm, 22.3 percent of true VT/VF episodes were shocked, resulting from the high efficacy of ATP, compared to 28.7 percent in the physician-tailored arm.

--In the empiric arm, 11.9 percent of all true SVT episodes were shocked, which can be attributed to the programming of SVT discriminators and the accuracy of Medtronic's Enhanced PR LogicTM detection algorithm. This compares to 26.1 percent of all true SVT episodes shocked in the physician-tailored arm.

--The empiric strategy resulted in a significant reduction of unscheduled hospital visits.

--The two programming strategies were equivalent in time to first all-cause shock.

--There was no statistical difference in mortality, adverse events or ATP accelerations between the two treatment groups.

"ICD patients have the challenge of coping with an unpredictable condition. Minimizing the number of shocks helps to maximize their quality of life and increase their feelings of control over their health," said Samuel Sears, PhD, medical psychology division head and associate professor, Department of Clinical and Health Psychology, University of Florida.

The EMPIRIC study, sponsored by Medtronic, is a worldwide, multi-center, prospective, one-to-one randomized clinical trial. EMPIRIC investigators followed 900 patients at 54 centers from the United States, Canada, United Kingdom, Austria, Saudi Arabia and Kuwait. A Medtronic Marquis(R) DR ICD was implanted in all 900 patients who were separated into two groups, standardized (445 patients) and physician-tailored (455 patients). Patients with primary prevention and secondary prevention indications were included in the two treatment groups.

"Medtronic continues to identify ways to optimize and simplify programming of ICDs to reduce shocks while also ensuring delivery of lifesaving defibrillation therapy when needed," said Medtronic CRM President Steve Mahle. "The EMPIRIC results, like the impressive Medtronic PainFREE Rx and PainFREE Rx II study results presented at prior Heart Rhythm Society meetings, demonstrate the importance of taking full advantage of sophisticated ICD features to improve patient quality of life."

Medtronic, Inc. (NYSE:MDT), headquartered in Minneapolis, is the world's leading technology providing lifelong solutions for people with chronic diseases. Its Internet address is www.medtronic.com.

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 30, 2004. Actual results may differ materially from anticipated results.