EU approves St. Jude's quadripolar pacing system

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St. Jude Medical has received CE Mark approval for its quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-D).

The quadripolar system, with the Quartet left ventricular pacing lead, features four pacing electrodes on the left ventricular lead, enabling up to 10 pacing configurations. Multiple pacing configurations provide physicians with more options to pace around scar tissue in the heart and avoid common pacing complications—such as unintentional phrenic nerve stimulation—without the need to surgically reposition the lead, according to the St. Paul, Minn.-based company.

The quadripolar CRT-D and Quartet pacing lead will be distributed via a limited launch in Europe, and will be used in the investigational devices exemption (IDE) trial for FDA approval of the commercialized device, which will be called the Promote Quadra CRT-D.