Healthcare Industry News:  cardiac resynchronization therapy 

Devices Cardiology Monitoring

 News Release - September 2, 2007

Medtronic to Present Key Clinical Evidence at European Society of Cardiology Congress

Device and Feature Performance, Risk Stratification, and Improvements in Managing Heart Failure Patients Are Focus of Clinical Evidence

MINNEAPOLIS & VIENNA, Austria--(HSMN NewsFeed)--In conjunction with the European Society of Cardiology Congress being held this week in Vienna, Austria, Medtronic, Inc. (NYSE:MDT ) announced results from several clinical studies regarding the treatment and management of heart failure patients, as well as post-myocardial infarction (MI) patient risk stratification. The clinical evidence presentations follow closely on CE Mark receipt for the Medtronic CareLink® Network and its capabilities of remotely and wirelessly monitoring heart failure patients with implantable cardiac devices in 14 countries around the world.


SEARCH-MI

SEARCH-MI (Survey to Evaluate Arrhythmia Rate in So-Called High Risk MI Patients) is a prospective, observational, multicenter study to document the incidence and prevalence of implantable cardioverter-defibrillator (ICD) interventions and ventricular arrhythmias for European ICD patients with a previous MI, also known as heart attack. These patients received ICDs as primary prevention because they are considered at risk for sudden cardiac arrest (SCA), but have not previously experienced a dangerous ventricular arrhythmia. The study was conducted at 69 centers and enrolled 788 patients who were followed for an average of two years. SEARCH-MI was presented today by Prof. Giuseppe Boriani, M.D., Ph.D., of Institute of Cardiology, University of Bologna and Azienda Ospedaliera S.Orsola-Malpighi in Bologna, Italy, as a Hotline Session. Results demonstrated that approximately one in five study participants benefited from successfully treated ventricular arrhythmic events by their ICD. The event rates are similar to those reported for the ICD arm of the MADIT II Trial, which studied a North American primary prevention population. Patients in the trial were also implanted with cardiac resynchronization therapy (CRT) devices, tailored to the needs of heart failure patients.

CARISMA

CARISMA (Cardiac Arrhythmias and Risk Stratification After Myocardial Infarction) is a multicenter study to investigate the ability of selected invasive and non-invasive tests, performed six weeks after an acute myocardial infarction (AMI), to predict an ICD-"treatable" arrhythmia. Presented today as a Poster Session, CARISMA documented the incidence of cardiac arrhythmias using the Medtronic Reveal® Plus insertable loop recorder (ILR) and demonstrated the utility of heart rate variability parameters as appropriate risk stratifier for post-MI patients.

To be presented later in the week at the ESC Congress: PROSPECT (Predictors of Response to CRT) is a prospective, multicenter study that evaluates the ability of selected baseline echocardiographic parameters to predict clinical or echocardiographic response to CRT.

Within Medtronic's clinical evidence portfolio, additional studies investigating acute myocardial infarction are underway. Further, the company's focus on heart failure includes clinical research into Medtronic's proprietary OptiVol® Fluid Status Monitoring, which measures changes in intrathoracic impedance. Using very low electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart), the system can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the thorax. Since normal fluid levels may 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 in conjunction with ongoing monitoring of other patient symptoms. The heart failure research includes, among others, SENSE-HF and DOT-HF:

SENSE-HF (Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure) is a prospective, observational, multicenter, event-driven, international study to evaluate the sensitivity and positive predictive value of the OptiVol® Fluid Trends data in predicting HF-related hospitalizations and health care utilizations associated with the signs and symptoms of worsening heart failure.

DOT-HF (Diagnostic Outcome Trial in Heart Failure) is a prospective, randomized, multicenter, event-driven, international study to investigate if there is a reduction in the combined endpoint of heart failure hospitalizations and all-cause mortality, in subjects randomized to "Access Arm" compared to "Control Arm" subjects. Access Arm patients are managed with standard clinical assessment and using OptiVol Fluid Status Monitoring with Cardiac Compass® Reports; Control Arm patients are managed with standard clinical assessment alone.

Since 1997, Medtronic has supported more than 20 randomized, controlled clinical studies evaluating device therapy in more than 8,000 heart failure and post-MI patients. This research has resulted in several medical "firsts," among them the first United States Food and Drug Administration-approved resynchronization device for the treatment of heart failure, based on results from the groundbreaking MIRACLE (Multicenter InSync Randomized Clinical Evaluation) trial; the first study of the risk of sudden cardiac death in a heart failure patient population with SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial); and the landmark CARE-HF (Cardiac Resynchronization in Heart Failure) trial, which demonstrated that patients with moderate and severe heart failure who received a Medtronic cardiac resynchronization therapy (CRT) device experienced a significant reduction in risk in mortality and morbidity, and that long-term treatment with CRT or CRT-D (with an ICD) is a cost-effective way to improve survival in patients with heart failure.

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 27, 2007. Actual results may differ materially from anticipated results.


Source: Medtronic

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