New Data Demonstrates Value of Cardiac Devices and Diagnostics in Managing Heart Failure Patients

New research shows cardiac resynchronization therapy (CRT) reduced the time to first heart failure hospitalization or death by nearly half in patients with mild heart failure, and devices equipped with OptiVol® Fluid Status Monitoring identified patients who were at a significantly higher risk (3.5 times) of having a heart failure event in the near future. The findings from the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) and PARTNERS HF (Multi-site Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients with Heart Failure) trials, both sponsored by Medtronic, Inc. (NYSE: MDT), were presented today as late breaking clinical trials during the 12^th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) in Toronto, and demonstrate the value of CRT and device diagnostics in managing heart failure patients and their hospitalizations.

REVERSE Key Findings

European patient data shows that CRT, in combination with optimal medical therapy (OMT), significantly reduced the risk of heart failure hospitalizations or death in the first 18 months over OMT alone in patients with asymptomatic or mild heart failure. Currently, CRT is indicated for patients with moderate or severe heart failure. Optimal medical therapy is considered to be beta blockers and ACE inhibitors or aldosterone-receptor blockers. At 18 months, 15.7 percent of study patients without CRT were hospitalized for heart failure or died versus 7.5 percent of heart failure patients studied with CRT; approximately a 50 percent reduction. Additionally, CRT is shown to help improve the heart’s pumping efficiency and reduce its size.

Presented by William T. Abraham, M.D., F.A.C.C., chief of Cardiovascular Medicine at The Ohio State University, with 610 patients studied, REVERSE is the first large-scale, global, randomized, double-blind trial to demonstrate the benefits of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms.

"Even in patients who generally have mild or no symptoms of heart failure, CRT can have a positive impact and delay the time to first heart failure hospitalization or death,” said Dr. Abraham. "Preventing the progression of heart failure with device therapy can lead to better patient outcomes and reduce economic burden to the hospital and health care system.”

Twelve-month REVERSE data has been presented at a number of scientific congresses in Europe and the United States. These results represent findings at 18-months for the European blinded cohort, which will be followed for 24 months. Despite the trial not meeting statistical significance for its primary endpoint (percent of patients worsened at 12 months using a heart failure Clinical Composite Score, which includes subjective and objective measures of heart failure status), more patients in the trial improved with CRT; this trend continues at 18 months.

PARTNERS HF Key Findings

PARTNERS HF data demonstrated that monitoring fluid trends in the chest cavity using OptiVol identified patients more likely to have subsequent heart failure events, such as shortness of breath, fatigue, tissue swelling due to fluid build up, and decompensation or deterioration of the heart. Patients with a fluid index crossing above a threshold of 100 ohm days during the 21 days prior to their six month visit were two times more likely to have a heart failure event in the following six months independent of other clinical variables. Another analysis that simulated more frequent monitoring demonstrated patients with a fluid index crossing were about 3.5 times more likely to have subsequent heart failure events independent of other clinical variables.

"These findings demonstrate that continuous device monitoring of heart failure patients in addition to periodic office visits can identify patients at increased risk for future heart failure events,” said David Whellan, M.D. M.H.S., associate professor of medicine at Thomas Jefferson University Hospital in Philadelphia. "Ongoing fluid monitoring can help me better manage my heart failure patients and intervene earlier before symptoms worsen.”

Dr. Whellan presented the initial findings from this 12-month prospective, multi-center, observational, unblinded study, which includes 707 CRT with defibrillation (CRT-D) patients.

About OptiVol

OptiVol Fluid Status Monitoring is found only on Medtronic cardiac resynchronisation therapy-defibrillators (CRT-Ds) and implantable cardioverter-defibrillators (ICDs). It uses low electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest – a common sign of heart failure. Since normal fluid levels vary from patient to patient, and fluid accumulation can be either slow or rapid, OptiVol’s ability to measure fluid status trends over time can provide important insights that are used in conjunction with ongoing monitoring of other patient signs and symptoms.

Heart Failure Research

Medtronic continues to pioneer research to demonstrate the utility of cardiac device therapy and heart failure guideline adherence involving approximately 56,000 heart failure patients worldwide. Following are the most notable ongoing trials:

• BLOCK HF (Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block) trial is determining the value of CRT in patients with AV block and at risk of developing worsening heart failure.
• IMPROVE HF (Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) was designed to quantify and improve quality of care for heart failure patients by promoting the use of evidence-based, guideline-recommended therapies.
• IRIS (Immediate Risk-Stratification Improves Survival) trial is designed to prove the benefit of ICDs in post-myocardial infarction patients with an ejection fraction of less than 40 percent.
• PRECEDE-HF/DOT-HF (Prospective Randomized Evaluation of Cardiac Compass with OptiVol in the Early Detection of Decompensation Events for Heart Failure)/(Diagnostic Outcome Trial in Heart Failure) trial is determining whether the use of Cardiac Compass including OptiVol® Fluid Status Monitoring with standard clinical assessment will result in a longer time to hospitalization or death compare to the use of only standard clinical assessments.
• RAFT (Resynchronization/Defibrillation for Advanced Heart Failure Trial) is comparing lives saved and hospitalizations in heart failure patients with CRT-Ds to those with ICDs.
• REDUCEhf (Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients with Chronic Heart Failure) trial seeks to determine the safety, efficacy and functionality of the investigational Chronicle® systems (Chronicle ICD and Chronicle IHM) when used in NYHA Class II and III heart failure patients.
• SENSE-HF (Improving Patient Management using OptiVol® Fluid Trends Data) trial is evaluating the sensitivity of Medtronic’s exclusive OptiVol Fluid Trends feature in predicting heart failure hospitalization with signs and/or symptoms of pulmonary congestion.

Caution: The CRT devices used in the REVERSE trial are investigational for the patient population studied; their use is limited by federal (or United States) law.

Caution: The Chronicle systems used in the REDUCEhf trial and the OptiVol CareAlert used in the PRECEDE HF trial are investigational for the patient population studied; their use is limited by federal (or United States) law to Investigational Use.

Note: The SENSE-HF and DOT-HF are post-market studies outside the United States for the OptiVol CareAlert. The indication is considered investigational within the United States.

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 25, 2008. Actual results may differ materially from anticipated results.