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|Medtronic Launches Large-Scale Clinical Trial to Examine Impact of Implantable Device-Based Monitoring Technology on Heart Failure Patient Care|
Study to Examine If More Frequent Review of Patient Data from Company’s Implantable Monitoring Technology Leads to Better Health Outcomes
MINNEAPOLIS – May 12, 2009 – Medtronic, Inc. (NYSE: MDT) today announced the start of a nationwide trial to examine the relationship between the company’s OptiVol® Fluid Status Monitoring technology and the ability to predict worsening heart failure, a leading cause of hospitalizations worldwide. The trial will assess whether more frequent (monthly vs. quarterly) review of patient data results in earlier clinical intervention.
“Medtronic has been the pioneer in the development of tools to aid in the early detection of worsening heart failure. The goal of this new trial, called OptiVol Care Pathway, is to provide physicians with clinical evidence to understand the role and application of comprehensive diagnostics, including fluid status monitoring, in managing heart failure patients,” said Marshall S. Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “Monitoring fluid trends via OptiVol can help physicians identify patients who are at risk of experiencing worsening heart failure events, but who may not experience symptoms.”
Previous studies have 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 heart function leading to hospitalizations. However, most physicians today rely on non-specific measures such as patient weight in an effort to detect worsening heart failure.
The commencement of the OptiVol Care Pathway trial complements a data analysis that will be presented during Heart Rhythm 2009, the annual scientific sessions of the Heart Rhythm Society, which utilized de-identified data aggregated in the Medtronic Discovery™ Hub on more than 43,000 ICDs and CRT-Ds. The analysis examined the association between worsening heart failure as indexed by OptiVol and atrial and ventricular tachyarrhythmias (AT and VT). Results from the analysis will be presented at the session, “Decreases in Intrathoracic Impedance Are Associated with Atrial and Ventricular Tachyarrhythmias: An Analysis of 43,356 CRT-D and ICD Devices,” at 10:45 a.m. Friday, May 15, in Room 255 at the Boston Convention and Exhibition Center.
About OptiVol Care Pathway
About OptiVol Fluid Status Monitoring
About Heart Failure1
1 Heart Disease and Stroke Statistics 2009 Update. A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation, published online Dec 15, 2008
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.
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