First Patients Enrolled in St. Jude Medical's Study Looking at AF Suppression Pacing in Heart Failure Patients.ST. PAUL, Minn. -- St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE See: New York Stock Exchange :STJ) today announced that patient enrollment has begun in the Atrial Fibrillation Suppression Pacing in Cardiac Resynchronization Therapy Devices (CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators ) clinical study. The study evaluates the Company's proprietary AF Suppression(TM) algorithm, clinically proven to suppress episodes of atrial fibrillation (AF), and how it impacts the effectiveness of cardiac resynchronization therapy in heart failure patients. "Episodes of atrial fibrillation may inhibit the delivery of cardiac resynchronization therapy, so the AF Suppression algorithm being evaluated in this study could play a critical complementary role in managing heart failure," said Scott Beau, M.D., of Little Rock Cardiology Clinic in Little Rock, Arkansas Little Rock, Arkansas required military intervention to desegregate schools (1957–1958). [Am. Hist.: Van Doren, 556–557] See : Bigotry , who enrolled the first patient and serves as a principal investigator in the study. Atrial fibrillation is a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition characterized by the rapid, unsynchronized quivering of the heart's atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. chambers. It affects more than two million Americans. Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. The economic burden of heart failure is estimated at $40 billion per year in the U.S. "Previous 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. studies have used devices programmed for atrial tracking (i.e., sensing intrinsic atrial activity) rather than atrial pacing, so this study should further advance our understanding of the efficacy of CRT in patients receiving implantable cardioverter defibrillators (ICDs)," said Eric S. Fain, M.D., Executive Vice President of Development and Clinical/Regulatory Affairs for St. Jude Medical's Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. Division. "Demonstrating that AF Suppression pacing is compatible with CRT would be an important finding, since a significant number of heart failure patients being treated with CRT also have paroxysmal paroxysmal (per´ adj recurring in paroxysms. atrial fibrillation." The AF Suppression(TM) algorithm offers a device-based approach engineered to suppress atrial fibrillation through "intelligent" overdrive stimulation in response to patient activity. Many previous atrial overdrive methods were based on fixed overdrive pacing, which can be uncomfortable for patients at rest or sleeping, and usually can't provide the high percentage of atrial pacing that is possible with AF Suppression(TM) technology. Patient criteria in the AF Suppression in CRT-D study include that they have had a St. Jude Medical(R) cardiac resynchronization therapy device with AF Suppression(TM) pacing implanted for at least three months, stable heart failure symptoms, and the ability to complete a six-minute hall walk test and quality of life questionnaire. This multi-center, 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. , blinded, controlled clinical study is being conducted at up to 30 clinical centers in the United States. St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value. Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Company's Quarterly Report on Form 10-Q filed on November 8, 2005 (see page 35). Actual results may differ materially from anticipated results. |
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