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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 -- In conjunction with the European Society of Cardiology The European Society of Cardiology (ESC) represents more than 50,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the impact of cardiovascular disease in Europe.  Congress being held this week in Vienna, Austria, Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT MDT
abbr.
Mountain Daylight Time


MDT (in the US and Canada) Mountain Daylight Time

MDT n abbr (US) (= mountain daylight time) →
) 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[R] 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 ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
) 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 (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ), 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 Nowadays, the University counts about 100,000 students in its 23 faculties. It has branch centers in Reggio nell'Emilia, Imola, Ravenna, Forlì, Cesena and Rimini and a branch center abroad in Buenos Aires.  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 ar·rhyth·mic
adj.
Lacking rhythm or regularity of rhythm.
 events by their ICD. The event rates are similar to those reported for the ICD arm of the MADIT MADIT Cardiology A clinical trial–Multicenter Automatic Defibrillator Implantation Trial that evaluated the effects of implanted defibrillators–IDs in Pts with CAD at high risk of ventricular arrhythmia  II Trial, which studied a North American primary prevention population. Patients in the trial were also implanted with cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library.

(2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons.
) 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 acute myocardial infarction (·kyōōtˑ mī·ō·karˑ·dē·  (AMI), to predict an ICD-"treatable" arrhythmia. Presented today as a Poster Session, CARISMA documented the incidence of cardiac arrhythmias using the Medtronic Reveal[R] Plus insertable loop recorder insertable loop recorder Cardiology An implantable Pt-activated monitoring system that records subcutaneous EKGs in Pts with Sx suggestive of arrhythmia. See Holter monitoring.  (ILR) and demonstrated the utility of heart rate variability Heart rate variability (HRV) is a measure of variations in the heart rate. It is usually calculated by analysing the time series of beat-to-beat intervals from ECG or arterial pressure tracings.  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[R] 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 Positive predictive value (PPV)
The probability that a person with a positive test result has, or will get, the disease.

Mentioned in: Genetic Testing

positive predictive value 
 of the OptiVol[R] 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 ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, 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[R] 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 Sudden Cardiac Death Definition

Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest.
 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 CRT-D Cardiac Resynchronization Therapy - Defibrillators  (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.
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Publication:Business Wire
Article Type:Clinical report
Date:Sep 2, 2007
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