FDA Approves St. Jude's Cool Point Irrigation Pump for RF Ablations


June 18, 2009

St. Jude Medical Inc. said the FDA approved its Cool Point Irrigation Pump, used in conjunction with St. Jude Medical (SJM) open-irrigated ablation catheters, to supply 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’ abilities 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 Irrigation Pump also provides monitoring and safety features designed to give physicians more control over therapy delivery, the company said. Physicians can 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. In addition, the pump has redundant bubble detectors, each designed to detect bubbles as small as two microliters.