Medtronic Initiates ''Concerto AT'' Study in United States; Clinicians Begin Implanting New Cardiac Resynchronization Therapy-Defibrillator with Atrial Therapies.MINNEAPOLIS -- Medtronic, Inc., (NYSE NYSE See: New York Stock Exchange :MDT) today announced the first implants in the United States of the Medtronic Concerto(TM) Cardiac Resynchronization Therapy Defibrillator (CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators ) with Atrial Therapies (AT). 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 send tiny electrical impulses to the heart muscle to resynchronize the contractions of the heart's lower chambers, helping the heart pump blood throughout the body more efficiently and reducing patients' heart failure symptoms. CRT-D devices also can deliver a shock to terminate a dangerously abnormal heart rhythm. The clinical study is a prospective, non-randomized, multi-center, global clinical trial involving up to 425 patients at approximately 50 sites in Europe, the United States and Japan. The purpose of the study is to assess the safety and efficacy of atrial defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. therapy in patients with a current indication for CRT and ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. . The Concerto(TM)/Virtuoso(TM) line of implantable devices, which includes the Concerto CRT-D and Virtuoso(TM) implantable cardioverter-defibrillator (ICD), will be Medtronic's first 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. products with Conexus(TM) Wireless Telemetry. Conexus Telemetry will enhance efficiencies at device implant and during in-office follow-up visits, as well as enable automatic, wireless data transmission from the patient's device to a home monitor. Device data then is transmitted to the clinician using the Medtronic CareLink(R) Network, the first Internet-based system to help physicians and patients better manage chronic cardiovascular disease treated by implantable device therapy. "Wireless transmission of data on how the device and patient's heart are operating, coupled with the device's therapeutic and monitoring features, hold promise for better patient care and more effective device management," said Dr. David Schwartzman, associate professor of medicine and director of the Atrial Arrhythmia Center at the University of Pittsburgh Medical Center The University of Pittsburgh Medical Center (UPMC) is a leading American healthcare provider and institution for medical research. It consistently ranks in US News and World Report's "Honor Roll" of the approximately 15 best hospitals in America. , and principal investigator for the Concerto AT study. Offering an array of Medtronic-exclusive features to help improve the care of heart failure patients, the Concerto AT CRT-D device includes: --Conexus(TM) Wireless Telemetry: Utilizing the Medical Implant Communication Service Medical Implant Communication Service (MICS) is the name of a specification for using a frequency band between 402-405 MHz in communication with medical implants. It allows bi-directional radio communication with a pacemaker or other electronic implants. (MICS) radio frequency band, 402-405 MHz, Medtronic Conexus Telemetry enables communication between the patient's implanted device and home monitor or clinician programmer at a range of two to five meters (approximately six to 16 feet). Communication between device and monitor can be initiated by the physician based on programmed device parameters, to occur at pre-scheduled dates and times, or pre-programmed via the Medtronic CareLink Network. The MICS band is a dedicated frequency designated by global telecommunications regulatory authorities, such as the Federal Communications Commission Federal Communications Commission (FCC), independent executive agency of the U.S. government established in 1934 to regulate interstate and foreign communications in the public interest. (FCC) in the United States, for implantable medical device communication. Use of the MICS band protects Medtronic wireless devices from interference caused by cell phones and other common electronic devices. --OptiVol(R) Fluid Status Monitoring: Measures changes in impedance in the thoracic cavity, the chest area encompassing the lungs and heart. Using very low electrical pulses that travel across the thoracic cavity, 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 that are used in conjunction with ongoing monitoring of other patient symptoms. --Left Ventricular Capture Management: LVCM LVCM Las Vegas Cable Modem LVCM Licentiate, Victoria College of Music is intended to automatically sense and adjust impulses for optimal stimulation of the heart's lower left chamber (ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular ventricle of Arantius the rhomboid fossa, especially its lower end. ). --ATP During Charging(TM): Automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed, with no delay. Anti-tachycardia pacing (ATP ATP: see adenosine triphosphate. ATP in full adenosine triphosphate Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms. ) has been clinically proven to eliminate three out of four shocks with painless pacing therapy. "The Concerto AT device, with Conexus Wireless Telemetry, represents a technological turning point for Medtronic and our industry. This system makes full use of the Medtronic CareLink Network as the cornerstone of our platform for wireless communication, and transforms CareLink from a device management tool to a disease management tool," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "Once again, Medtronic innovations are being leveraged across our business to bring new therapies and standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given to cardiac disease patients who can benefit from them." 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 Quarterly Report on Form 10-Q for the quarter ended October 28, 2005. Actual results may differ materially from anticipated results. |
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