FDA Approves V-V Timing Feature For Medtronic InSync Sentry And InSync Maximo Systems

Medtronic, Inc. (NYSE:MDT) today announced it received approval by the U.S. Food and Drug Administration (FDA) to add sequential biventricular pacing or "V-V (ventricle to ventricle) timing" to its InSync Sentry(TM) and InSync Maximo(TM) cardiac resynchronization therapy defibrillators (CRT-Ds). V-V timing allows physicians to separately adjust the timing of electrical therapy delivered to the heart failure patient's two ventricles, which can optimize the beating of the heart and enhance the flow of blood throughout the body.

Starting in the next two weeks, shipped InSync Sentry and InSync Maximo devices will include V-V timing. In addition, special software will be released to allow patients who already have a previous model of these devices to benefit from the feature through a simple, in-clinic software programming change.

In addition, FDA approved a labeling modification for InSync Sentry and InSync Maximo systems to include use for heart failure patients who have prolonged QRS duration.

"Adjustment of ventricle timing can be especially beneficial when patients need every bit of pumping power," said William Abraham, M.D., chief of cardiology at The Ohio State University. "This advantage will be significant for many patients, including those who already have a Medtronic InSync Sentry or InSync Maximo, since they won't need to undergo another implant to take advantage of this important benefit."

At the Heart Rhythm Society Annual Scientific Sessions on May 6, Dr. Abraham will present clinical data about patient response to V-V timing in the InSync III Marquis(TM) clinical trial, a Medtronic-sponsored randomized, double-blind controlled study evaluating the safety and effectiveness of sequential biventricular pacing.

"Medtronic is improving the management of heart failure with continual advancements like sequential biventricular pacing and breakthrough products like InSync Sentry," said Steve Mahle, Medtronic Cardiac Rhythm Management president. "Our aim is to help patients experience a better quality of life while also helping physicians and hospitals contain healthcare costs."

CRT resynchronizes the contractions of the heart's ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently and reduce heart failure symptoms. The defibrillation capability applies electrical impulses to stop potentially lethal heart rhythms. According to the American Heart Association, patients with heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population.

Medtronic CRT-D systems are the most widely implanted CRT-D systems in the world, and the company's CRT-D product portfolio includes devices with the longest battery life available and unique features not available in competitive devices. For example, the InSync Sentry system is the world's first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, the chest area encompassing the lungs and heart. This advance is expected to provide a critical advantage in managing heart failure, since thoracic fluid accumulation is a primary indicator of worsening heart failure and often results in patient hospitalization.