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Medtronic Commences Large-Scale Clinical Trial to Evaluate ...

...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(TM) 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 deve...