St. Jude Medical Announces FDA Approval of the Cool Point Irrigation Pump

Automated irrigation pump provides control over fluid delivery during radiofrequency (RF) catheter ablation procedures.

St. Jude Medical, Inc. today announced U.S. Food and Drug Administration (FDA) approval of its Cool Point™ Irrigation Pump. Used in conjunction with SJM open-irrigated ablation catheters, an irrigation pump supplies a continuous flow of saline through the catheter’s inner lumen to cool the ablation electrode for more effective energy delivery. Designed to enhance physicians’ ability to perform successful atrial ablations, the new Cool Point irrigation pump was developed specifically for use with the company’s IBI-1500T9-CP cardiac ablation generator and family of Therapy™ Cool Path™ irrigated catheters.

“The Cool Point pump is part of a fully integrated system that has been designed for easy set up and seamless operation with our latest cardiac ablation generator and our growing family of Therapy Cool Path open-irrigated catheters,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “By introducing the Cool Point Irrigation Pump, we provide plug-and-play connectivity with the lab’s existing St. Jude Medical equipment.”

In addition to the intuitive setup and operation, the Cool Point Irrigation Pump provides monitoring and safety features, which are designed to give physicians more control over therapy delivery. This interface enables physicians to monitor the total volume of irrigation solution delivered through an easy-to-read display.

The pump’s proprietary tubing includes an in-line occlusion detector, which monitors flow pressure between the pump and the catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate (an indication that irrigation ports on the catheter tip may be blocked and the tip cooling may not be effective). In addition, the pump has redundant bubble detectors, each designed to detect bubbles as small as two microliters. Bubbles in the bloodstream may lead to embolism or stroke.

Catheter ablation therapy is used by physicians to restore a normal heart rhythm in patients with, typical atrial flutter. During cardiac ablation, an electrophysiologist (EP) uses a catheter (a thin, flexible tube) to deliver energy that creates lesions in specific areas of cardiac tissue. The lesions, or tiny scars, interrupt the abnormal electrical signals that contribute to erratic heart rhythms.

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. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit

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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 2009. 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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