St. Jude Medical Announces U.S. Release of Pacesetter Passive Plus DX Pacing Lead

St. Jude Medical, Inc. announced it has received U.S. Food and Drug Administration (FDA) approval for market release of the Pacesetter Passive PlusDX passive-fixation pacing lead. St. Jude Medical's Cardiac Rhythm Management Division (CRMD) markets both Pacesetter pacing systems and Ventritex defibrillation systems.

The letters ``DX'' in the product names indicate use of less than one milligram of the steroid Dexamethazone Sodium Phosphate in a controlled release device housed in the tip of the lead. The steroid is intended to suppress the body's inflammatory response to a foreign substance and contribute to lower capture thresholds. Lower capture thresholds allow programming of lower pacemaker output settings which can maximize pacing system longevity.

In addition, Pacesetter Passive Plus DX and Tendril DX lead tips are coated with titanium nitride, which improves the leads' sensing ability and promotes low polarization. Both leads are also insulated with silicone, which has a 30-year clinical record of reliability as an implant material, and coated with Fast-Pass, a proprietary molecular coating that improves lubricity for easier venous passage during the pacemaker implantation procedure when two leads are inserted into the same vein.

Passive Plus DX and Tendril DX leads are available in lengths appropriate for both atrial and ventricular placement.

St. Jude Medical, Inc. develops, manufactures and distributes medical devices for the cardiovascular market.