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ACC.08 Late Breaking Clinical Trials Document Advancements in Medical Device Research, Underscore Medtronic Leadership in Clinical Evidence.


Appropriate Device Use in At-Risk Patients Among Focus of Ongoing and Future Clinical Trials

MINNEAPOLIS & CHICAGO -- As ACC See adaptive cruise control. .08, the annual congress of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S.  nears its close, Medtronic Inc. (NYSE NYSE

See: New York Stock Exchange
: MDT) reaffirms its commitment to clinical evidence supporting the full range of implantable cardiac device therapy as standard of care for patients with heart failure, arrhythmias and those at risk of sudden cardiac arrest (SCA). As evidenced by today's Late Breaking Scientific Sessions on three Medtronic-sponsored clinical trials, and poster data presented earlier in the congress, Medtronic continues to advance clinical science that impacts medical practice worldwide.

"Our investment in clinical research - measured by both the size and scope of trials in which we're involved worldwide - is unsurpassed in the cardiac device industry," said David M. Steinhaus, M.D., vice president and medical director of the Cardiac Rhythm Disease Management business at Medtronic. "This commitment is critical to scientific and medical advancement and is another way in which we provide greater access to life-saving and life-improving therapies."

Medtronic's continued study of certain cardiac tests and risk markers seeks to better identify and treat patients at risk for SCA. The company will soon announce details of several major clinical trials, including VEST / PREDICTS (The Vest Prevention of Early Sudden Death Trial / The Prediction of ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
 Therapies Study), a study designed to develop and validate a tool that predicts which post-MI (myocardial infarction, or heart attack) patients are at greatest risk of SCA. These initiatives are part of a National Institutes of Health (NIH "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
) grant awarded to the University of California-San Francisco (UCSF) and are co-funded by several industry partners.

Three Medtronic-sponsored studies were presented today at ACC.08 Late Breaking Clinical Trials:

* CARISMA (Cardiac Arrhythmias and Risk Stratification after Myocardial Infarction) showed that many arrhythmias are predictors of cardiac death for up to two years from the acute phase in post-MI patients with ejection fraction (EF) - a measure of the heart's pumping ability - of [?]40 percent. Devices such as 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 Reveal[R] DX, the company's newest insertable cardiac monitor (ICM), can monitor asymptomatic arrhythmias and can be appropriate patient management tools for assessing post-MI patients who may benefit from drug or device (pacemaker or ICD) therapy.

* It's known that patients with sustained atrial fibrillation (AF) are at increased risk of stroke. To further advance evidence on stroke, Medtronic sponsored the TRENDS trial, which looked at thromboembolic thromboembolic

pertaining to or emanating from thromboembolism.


thromboembolic meningoencephalitis
see hemophilosis.

thromboembolic parasitism
see thromboembolic colic.
 events, or TE (ischemic stroke, transient ischemic attack Transient Ischemic Attack Definition

A transient ischemic attack, or TIA, is often described as a mini-stroke. Unlike a stroke, however, the symptoms can disappear within a few minutes.
 [TIA (1) (Telecommunications Industry Association, Arlington, VA, www.tiaonline.org) A membership organization founded in 1988 that sets telecommunications standards worldwide. It was originally an EIA working group that was spun off and merged with the U.S. ], or non-stroke systemic embolism embolism

Obstruction of blood flow by an embolus—a substance (e.g., a blood clot, a fat globule from a crush injury, or a gas bubble) not normally present in the bloodstream. Obstruction of an artery to the brain may cause stroke.
), in patients with implanted cardiac devices using Medtronic's Cardiac Compass[R] Reports. Providing up to 14 months of clinical data, the reports show tracked arrhythmia episodes, therapies delivered, physical activity, heart rate, and other device and physiologic data. The TE rate in the study was low compared to past pharmacological trials of stroke. This prevented analysis of the primary objective of the study, whether AT/AF burden over 30 days is an independent predictor of thromboembolic events in subjects not receiving anticoagulation therapy. Nonetheless, the results from post-hoc analysis suggest that AT/AF burden, as reported by Cardiac Compass Reports, of 5.5 hours on any day during the preceding 30 days may double the risk for TE, independent of known risk factors and antithrombotic therapy.

* REVERSE (Resynchronization Reverses Remodeling in Systolic Systolic
The phase of blood circulation in which the heart's pumping chambers (ventricles) are actively pumping blood. The ventricles are squeezing (contracting) forcefully, and the pressure against the walls of the arteries is at its highest.
 Left Ventricular Dysfunction) was the first large-scale, global, 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.
, double-blind trial to evaluate 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.
) in asymptomatic or mildly symptomatic heart failure patients (NYHA Class I, II). Despite the trial not meeting statistical significance for the pre-specified analysis of its primary endpoint of a heart failure Clinical Composite Score at 12 months, more patients in the trial improved with CRT. The Clinical Composite Score is a measure of both subjective and objective assessments. Additionally, in a secondary endpoint, the trial showed that CRT leads to improvement in cardiac structure and function as measured by echocardiography Echocardiography Definition

Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and
, meaning the heart size is reduced and therefore acts as a more-efficient pump.

"I believe this data indicates that in this study, CRT in combination with optimal medical therapy improved left ventricular function in this population of heart failure patients," said Dr. Cecilia Linde of Karolinska University Hospital The Karolinska University Hospital or Karolinska Universitetssjukhuset is a university hospital in Stockholm, Sweden, with two major sites in the municipalities of Huddinge and Solna. , Stockholm, Sweden, worldwide principle investigator for the REVERSE trial. "Another observation is that over the 12-month follow-up period, CRT in mildly symptomatic patients delayed the time to first heart failure hospitalization."

Also presented at ACC.08 earlier this week were results from the MASTER II (Microvolt microvolt

one-millionth (10-6) of a volt; abbreviated µV.
 T Wave Alternans T-wave alternans (TWA) is a non-invasive test of the heart that is used to identify patients who are at increased risk of sudden cardiac death. It is most often used in patients who have had myocardial infarctions (heart attacks) or other heart damage to see if they are at high  Testing for Risk Stratification of Post MI Patients) trial, which concluded that MTWA test result does not significantly discriminate risk of life-threatening ventricular tachyarrthythmic events (LTVTE) in patients with a previous MI and left ventricular (LV) EF between 31-40 percent, although the incidence of LTVTEs in community practice was low. Further, a second poster from the MASTER trial titled, "Evaluation of MTWA test result concordance over time in the MASTER trial," explored how MTWA test results change over time. Essentially, year-to-year changes in MTWA test results are common in patients with ischemic Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.

Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation


ischemic
 LV dysfunction, which has important implications for patient testing.

"Each step we take with clinical research advances science and the base of evidence regarding the safety and efficacy of device therapy," Steinhaus added. "Though every trial may not achieve statistically significant results, what we learn from the process and findings contribute to new scientific understanding. We firmly believe in building a strong and evolving base of clinical evidence to inform medical practice and benefit patients worldwide."

Medtronic's commitment to clinical evidence includes more than 100 clinical trials scoped to include more than 100,000 patients worldwide. Among these landmark studies:

* SCD-HeFT (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 Heart Failure) trial, which showed that the use of an ICD in people with heart failure reduces death by 23 percent;

* CARE-HF (Cardiac Resynchronization in Heart Failure) trial, which demonstrated that CRT reduced death by 40 percent in patients with moderate to severe heart failure;

* MIRACLE (Multicenter InSync Randomized Clinical Evaluation) trial, which resulted in the United States Food & Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval of the first CRT device for the treatment of heart failure;

* IMPROVE HF (Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), the largest multifaceted heart failure study in the United States outpatient setting. It is designed for clinicians who want to improve patient outcomes by increasing awareness and adoption of published heart failure treatment guidelines, which are shown to reduce the risk of death by 77 percent;

* MOMIJI (Miracle-ICD Outcome Measured In Japanese Indication) trial, the first large-scale, post-market study in Japan sponsored by a medical device company.

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.

Notes to editors: Interviews are available with Dr. David Steinhaus, vice president and medical director of the Cardiac Rhythm Disease Management division at Medtronic, along with clinical trial investigators Dr. Poul Erich Bloch Thomsen (CARISMA), Dr. Taya Glotzer (TRENDS), Dr. Cecilia Linde (REVERSE), or Dr. Theodore Chow (MASTER I, II), by contacting Tracy McNulty at 612.819.2190.

VEST/PREDICTS disclaimer: The information stated above was prepared by Medtronic Inc. to report research strategies and reflects solely the opinion of Medtronic. Nothing in this statement shall be construed to imply any support or endorsement of Medtronic or any of its products by the Regents of the University of California The Regents of the University of California make up the governing board of the University of California. The Board has 26 full (i.e., voting) members:
  • The majority (18 Regents) are appointed by the Governor of California for 12-year terms.
, its officers, agents and employees.

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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