Medtronic Announces Japanese Introduction Of Cardiac Resynchronization Therapy With Defibrillator Capabilities (CRT-D) For Heart Failure Patients
First reimbursement approvals for CRT-D allow Japanese patients access to advanced therapies for the treatment of both heart failure and sudden cardiac arrest
MINNEAPOLIS and TOKYO – July 7, 2006 – In conjunction with the Japan Heart Rhythm Society annual meeting currently underway in Tokyo, today Medtronic announced Ministry of Health, Labor and Welfare (MHLW) approval of the Medtronic InSync III Marquis 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 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). 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 ICD, 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 feature, which notifies patients with a series of tones when follow-up care is needed.
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 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 approved the original InSync 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.
Medtronic, Inc. (www.medtronic.com - NYSE: MDT), 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 28, 2006. Actual results may differ materially from anticipated results.
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