St. Jude Bipolar Lead Gets FDA OK

St. Jude Medical, a developer of devices to treat cardiovascular disease, said that it received FDA approval for its QuickSite 1056T bipolar lead, a device that aids stability and shortens procedure times in cardiac resynchronization therapy (CRT) for heart failure patients.

In its clinical study, the QuickSite bipolar lead had a more than 96 percent rate of avoiding complications, a low 1.5 percent dislodgment rate, and a high impedance, which can improve device longevity. The company also reported no diaphragmatic/phrenic nerve stimulation complications at three months.

The company said it plans to launch the product in the U.S. before May 4. St. Jude already has a unipolar lead approved for use in the U.S. and internationally.