FDA approves St. Jude Medical's Safire BLU and Therapy Cool Path irrigated ablation catheters

St. Jude MedicalApr 4 2011

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that it has received U.S. Food and Drug Administration (FDA) approval of two new irrigated ablation catheters - the Safire BLU™ Bi-directional Irrigated Ablation Catheter and the Therapy™ Cool Path™ bi-directional ablation catheter. These two new catheters have several key design features that offer physicians additional control, including bi-directional deflection, a new shaft with higher torque response, a lower fluid infusion rate when compared to other commercially available irrigated ablation systems, and a choice of handles.

“The improved handling and catheter control of our new bi-directional catheters can assist physicians in accessing difficult-to-reach anatomic locations. This will allow for more predictable, repeatable and effective lesion formation so physicians can focus their attention on the patient”

St. Jude Medical ablation catheters are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart's ability to effectively pump blood throughout the body. Ablation catheters are thin flexible tubes that deliver radiofrequency (RF) energy to specific areas of cardiac tissue in order to create lesions, or tiny scars, that interrupt the abnormal electrical signals that contribute to irregular heart rhythms. Because the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature, the Safire BLU and Therapy Cool Path ablation catheters were designed with an irrigated catheter tip. Irrigation can help to reduce some of the risk factors associated with the heat of the RF energy.

The Safire BLU and Therapy Cool Path irrigated ablation catheters feature a bi-directional deflection capability that provides enhanced maneuverability, which allows physicians to reach challenging anatomic locations. The bi-directional steering turns up to 180 degrees in both directions to allow physicians to better position the tip of the catheter during ablation procedures. This flexibility promotes efficiency and was designed to provide electrophysiologists with increased control over their delivery of ablation therapy.

The bi-directional steering in these catheters is complemented by a shaft that is designed to more efficiently transmit torque (or turning force) from the steering handle to the catheter tip. This improved capability enables the physician to position the catheter with greater precision.

"The new bi-directional irrigated ablation catheters from St. Jude Medical offer innovative features that provide additional control when treating cardiac arrhythmias. The torque response, catheter tip stability and ability to make very fine movements result in excellent catheter performance in complex ablations," said Dr. Larry A. Chinitz, Director of Cardiac Electrophysiology and Invasive Cardiology at New York University School of Medicine.

The handles of the Safire BLU and Cool Path catheters were designed to be ergonomically appealing and provide physician comfort for both routine and complex ablation procedures. Physicians have the flexibility to choose the handle style that they prefer - the ComfortGrip™ for the Safire BLU catheter or push/pull style handle for the Therapy Cool Path catheter.

"The improved handling and catheter control of our new bi-directional catheters can assist physicians in accessing difficult-to-reach anatomic locations. This will allow for more predictable, repeatable and effective lesion formation so physicians can focus their attention on the patient," said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. "St. Jude Medical is pleased to offer these two new catheters and provide physicians the unique benefits of bi-directional steering, along with the choice of handle that best suits their preference."