Medtronic Announces Japanese Introduction of Cardiac Resynchronization Therapy with Defibrillator Capabilities for Heart Failure Patients.MINNEAPOLIS & TOKYO -- First Reimbursement Approvals for CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators Allow Japanese Patients Access to Advanced Therapies for the Treatment of Both Heart Failure and Sudden Cardiac Arrest cardiac arrest n. Abbr. CA A sudden cessation of cardiac function, resulting in loss of effective circulation. Cardiac arrest A condition in which the heart stops functioning. In conjunction with the Japan Heart Rhythm Society annual meeting currently underway in Tokyo, today Medtronic announced Ministry of Health, Labor and Welfare (MHLW MHLW Ministry of Health, Labor and Welfare (Japan; formerly Ministry of Health and Welfare, MHW) MHLW Mean High Low Water (tide level) ) approval of the Medtronic InSync III Marquis(TM) cardiac resynchronization therapy-defibrillator (CRT-D) in Japan. In addition, MHLW has granted reimbursement approvals for CRT-D devices as a result of Medtronic's work with the Japanese regulatory body. The InSync III Marquis system combines cardiac resynchronization and 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. therapies in a single device for the treatment of moderate to severe heart failure in patients who are at risk for sudden cardiac arrest (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ). The device will be available for sale in Japan Aug. 1, 2006. "Medtronic is committed to providing the best possible solutions for patients with heart failure," said Marshall Stanton, M.D., vice president and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan. "We are pleased with the collaboration with MHLW to bring CRT-D therapy to Japanese patients, continuing Medtronic's 30-year tradition of leadership in Japan. Beginning with the introduction and reimbursement of ICDs in Japan in 1996 to cardiac resynchronization therapy-pacemakers in 2004, and now CRT-D, we continue to innovate to bring forward novel therapies and technologies for managing heart failure and heart rhythm disorders, benefiting physicians and their patients." About the size of a small stopwatch, the InSync III Marquis device offers sequential bi-ventricular pacing for more precise pacing of the two lower chambers of the heart - and a comprehensive heart failure management report to assist physicians in overall management of heart failure symptoms. In addition, the InSync III Marquis system includes the advanced therapies of the Marquis DR(R) ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. , the most popular ICD in Japan, which rapidly detects and terminates fast ventricular heart rates that could lead to SCA. Sudden cardiac arrest takes the lives of approximately 80,000 people in Japan annually. ICDs have been proven to be 99 percent effective in treating these potentially lethal rhythms. The InSync III Marquis system also includes the proprietary Medtronic Patient Alert(TM) feature, which notifies patients with a series of tones when follow-up care is needed. Heart Failure Heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body's tissues. Unlike a heart attack, heart failure is a condition that typically develops slowly, as the heart muscle weakens and needs to work harder to keep blood flowing through the body. When the heart is not pumping properly, even mild activity can cause shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. or difficulty breathing. Cardiac resynchronization therapy is designed to coordinate the contraction of the heart's two lower chambers and improve the heart's efficiency to increase blood flow to the body. More than 1.5 million Japanese suffer from heart failure, the only major cardiac condition that continues to grow in prevalence, which is reaching epidemic proportions and increasingly burdensome on the healthcare system. Medtronic pioneered cardiac resynchronization therapy and the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. approved the original InSync(R) system in August 2001. The InSync III Marquis CRT-D device has previously been approved for use in geographies around the world, including the United States and Europe. About Medtronic Medtronic, Inc. (www.medtronic.com) (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ), 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended April 28, 2006. Actual results may differ materially from anticipated results. |
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