Medtronic Commences Large-Scale Clinical Trial to Evaluate Effectiveness of CRT-D in Japanese Patients

Medtronic (NYSE:MDT) today announced the start of its MOMIJI (Miracle-ICD Outcome Measured In Japanese Indication) clinical trial; the first large-scale, post-market study conducted in Japan sponsored by a medical device company. The MOMIJI trial, which is a prospective, multi-center study enrolling up to 250 patients at approximately 25 centers in Japan, will evaluate the effectiveness of cardiac resynchronization therapy-defibrillator (CRT-D) in Japanese patients as compared to patients studied in the MIRACLE-ICD trial. The MIRACLE-ICD study was a randomized, double-blinded, parallel-controlled clinical trial to evaluate the efficacy of CRT-D in heart failure patients in the United States.

This trial is the result of collaboration between Medtronic Japan and three renowned Japanese physicians: two heart failure specialists, Dr. Shin-ichi Momomura, Professor of Jichi Medical University Omiya Medical Center, and Dr. Hiroyuki Tsutsui, Professor of Hokkaido University; and one electrophysiologist (heart rhythm specialist), Dr. Kaoru Sugi, Professor of Toho University Ohashi Medical Center. The first enrollments were by Dr. Momomura and occurred at the Jichi Medical University Omiya Medical Center.

“I am very excited to be part of this post-market study,” said Dr. Shin-ichi Momomura, the principle investigator of the trial. “The use of CRT-D therapy in patients worldwide has produced encouraging outcomes, but we want to learn more about its effectiveness in the Japanese patients.”

Since 1997, Medtronic has supported more than 20 randomized controlled trials evaluating device therapy in more than 8,000 heart failure patients outside of Japan. These trials have confirmed the efficacy of implantable cardioverter-defibrillators (ICDs) and CRT among certain heart failure patients, including the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) and Cardiac Resynchronization in Heart Failure (CARE-HF) studies. However, this is the first trial that will focus on the effectiveness of CRT-D therapy in a Japan-only cohort; as a result, the study may help determine if the results of foreign trials apply to the Japanese population.

“Medtronic is committed to bringing the newest and best therapies to improve people’s lives in Japan,” said Marshall Stanton, M.D, vice president and general manager of the Cardiac Rhythm Disease Management business for Medtronic in Japan. “The best way to do this is by proving the benefits of therapies through scientific clinical trials.”

Eligible devices for this trial include InSync III Marquis™ CRT-D, the number one selling CRT-D device in Japan, and future Medtronic CRT-D devices as they become commercially available. 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 received reimbursement approval in August 2006 and has been commercially available for six months.

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 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. Heart failure is reaching epidemic proportions and becoming increasingly burdensome on the healthcare system globally.

About Medtronic
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.