Medtronic, Inc announced that it has launched the InSync cardiac resynchronization therapy system in Japan, bringing an important new therapy for people suffering from heart failure to another major global market. InSync is an implantable device about the size of three large stacked coins that helps resynchronize the left and right sides of the heart so that it pumps blood more efficiently and helps patients feel better.
Approximately 1 million people in Japan suffer from heart failure, a chronic, progressive condition in which the heart has been damaged and fails to pump enough blood to meet the body's needs. Many patients with this condition develop a "dysynchrony" in the beating of the heart. In most cases, the InSync device corrects this dysynchrony by stimulating both sides of the heart with pacing pulses to return it to a more coordinated beating action.
Medtronic received import approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) last year and reimbursement coverage on April 1, 2004. The approval from the MHLW to sell the InSync system in Japan expands the company's goal of offering this heart failure therapy on a worldwide basis. It has been available in the United States, Europe, Australia, Canada, China and other countries in Asia for some time.
Medtronic is the only company offering cardiac resynchronization therapy to patients with heart failure in Japan.
"This is an exciting time for patients in Japan and for Medtronic, as we bring an important new medical therapy to another part of the world," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "The rapid acceptance of cardiac resynchronization therapy by the global medical community has been gratifying, and the growing body of clinical evidence of its benefits demonstrates that many more patients can be helped to fight this debilitating condition."