Download Medtronic Launches Large-Scale Clinical Trial to Examine Impact of

Medtronic Launches Large-Scale Clinical Trial to Examine Impact of Implantable Device-Based Monitoring
Technology on Heart Failure Patient Care
May 12, 2009 3:45 PM ET
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
OptiVol Care Pathway is a prospective, randomized, multicenter, clinical trial that will assess the impact of monthly vs. quarterly
review of OptiVol with Cardiac Compass™ Trend information on patient care. The study is expected to enroll approximately
1,500 patients at up to 200 sites; patients will be followed for 12 months. Principal investigator is W.H. Wilson Tang, M.D.,
assistant professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. First
enrollments in the OptiVol Care Pathway trial took place at Metropolitan Cardiology Consultants (Coon Rapids, Minn.) by Amin
Rahmatullah, M.D., and Carolina Heart Specialists (Gastonia, N.C.) by Mark Thompson, M.D.; enrollments continue at centers
nationwide.
About OptiVol Fluid Status Monitoring
OptiVol is found on Medtronic’s latest wireless defibrillators (Consulta™ and Concerto® CRT-Ds, Secura™ and Virtuoso®
ICDs), and has been available on Medtronic devices since U.S. Food and Drug Administration approval in 2004. OptiVol fluid
status monitoring uses low-level 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 in conjunction with other key device trends and physiologic measures available in Medtronic’s proprietary Cardiac Compass
Reports can provide the opportunity to intervene before patient symptoms develop. As of Jan. 1, 2009, the U.S. Centers for
Medicare and Medicaid Services have begun reimbursing physicians for their time spent monitoring heart failure patients using fluid
trend data obtained from Medtronic implantable cardiac devices via CareLink® Network remote transmission.
About Heart Failure1
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An estimated 5.7 million Americans have heart failure, and new cases are diagnosed in this country at a rate of another 670,000
annually. Each year, heart failure accounts for more than 1 million hospitalizations, is associated with nearly 300,000 deaths, and
costs more than $37 billion. Most of the hospitalizations are characterized by excessive fluid accumulation in the chest cavity.
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
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.
Medtronic Media Contacts:
Jeff Warren, Investor Relations, 763-505-2696
Kyra Schmitt, Public Relations,
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