St. Jude Medical receives approval for CRT-D quadripolar pacing system in India

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the approval of the industry's first quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds) in India. The Promote Quadra™ CRT-D offers physicians the ability to more effectively and efficiently manage the ever-changing pacing needs of patients with heart failure.

Cardiac resynchronization therapy, which can be delivered in an implantable cardioverter defibrillator (ICD) or a pacemaker, resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. Approximately 23 million people worldwide are afflicted with congestive heart failure (CHF), and 2 million new cases of CHF are diagnosed each year worldwide.

The quadripolar technology integrates multiple pacing configurations and features that enable physicians to optimize the system at implant and throughout the life of the patient, as well as better manage common complications without having to expose the patient to additional surgeries. St. Jude Medical is the only company to offer quadripolar pacing.

The Quartet™ left ventricular pacing lead is used as part of the quadripolar pacing system. It is the first lead to feature four electrodes that enable up to 10 pacing configurations. Multiple pacing configurations allow the physician more options including pacing closer to the base of the left ventricle, which recent studies associate with better patient outcomes and which may be less possible with leads that have only two electrodes. The quadripolar pacing electrodes also provide physicians additional benefits, such as pacing around scar tissue in the heart and avoiding the most common pacing complications.

Common pacing complications that can occur in patients implanted with a CRT system include high pacing thresholds and unintentional phrenic nerve or diaphragmatic stimulation. Patients with high pacing thresholds require significantly higher energy to pace the heart; this may reduce the device's battery life or cause pacing to fail. Phrenic nerve and diaphragmatic stimulation occur when the electrical output from a device inadvertently activates the diaphragm muscle (either directly or via the phrenic nerve), causing hiccups upon each pacing stimulus. Both high pacing thresholds and phrenic nerve or diaphragmatic stimulation are often due to the location of the pacing lead electrode.

"High pacing thresholds and phrenic nerve capture have been major problems with LV leads. This new quadripolar LV lead offers different pacing vectors and helps us to choose a vector which is devoid of Phrenic nerve capture. Altering pacing polarity may offer a lower pacing threshold, which is likely to improve the battery longevity," said Dr. Calumbur Narsimhan, Director of Arrhythmia-Electrophysiology Services at CARE Hospital in Hyderabad.

The Promote Quadra CRT-D and Quartet pacing lead have both received European CE Mark approval.

Source:

 St. Jude Medical

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