St. Jude Medical Announces FDA Approval Of The Cool Point Irrigation Pump

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 18 Jun 2009 - 5:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) 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.

Source
St. Jude Medical