Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - April 4, 2011

St. Jude Medical Receives FDA Approval for New Bi-Directional Ablation Catheters

Bi-directional catheters provide improved maneuverability and new shaft design allows for better handling

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- 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.

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.”

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended January 1, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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