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News

St Jude Medical achieves CE Mark approval for Integrated Irrigation Pump and Cardiac Ablation Generator

St Jude Medical : 05 February, 2008  (New Product)
St. Jude Medical has received European CE Mark approval of two integrated components: the Cool Point Irrigation Pump and the IBI-1500T11 Cardiac Ablation Generator.
Designed to enhance physicians' ability to perform successful cardiac ablations, the integrated components were developed for use together with the St. Jude Medical family of Therapy Cool Path irrigated catheters.

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

'The pump has been designed for easy set up and seamless operation with our cardiac ablation generator and for compatibility with our Therapy Cool Path open-irrigated catheters,' said Peter Chen, president of Irvine Biomedical, a St. Jude Medical company. 'Open-irrigated catheters have been proven to effectively create deeper and larger lesions while using less energy than standard therapy catheters.'

In addition to simplicity in set up and operation, the Cool Point Irrigation Pump provides important control, monitoring and safety features. The pump enables physicians to program the flow rate they determine to be optimal - up to 40 milliliters per minute - and 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 that monitors flow pressure between pump head and 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. In addition, the pump has redundant bubble detectors, each able to detect bubbles as small as two microliters (bubbles in the bloodstream can lead to embolism or stroke).

The new generator is designed specifically for ease of use with the Cool Point Irrigation Pump. Providing up to 150W of power, it is programmed for fully-automated communication with the pump. Its display provides real-time indication of pump communication. An optional remote control is available for added convenience.

The fully-integrated pump and generator accommodate the Therapy Cool Path family of open-irrigated catheters, which are designed to maintain lower tip-to-tissue temperatures, thereby creating wider and deeper lesions.

The Cool Path family was recently expanded with the European CE Mark approval of the Cool Path Duo irrigated ablation catheter, which is designed for uniform cooling of the entire length of the tip electrode. Featuring 12 irrigation ports - six on the proximal (near) and six on the distal (far) end of the electrode - the design of the Cool Path Duo has demonstrated measurable lower ablation electrode temperature when compared with a six-outlet port irrigated catheter. While providing uniform cooling with 12 irrigation ports, the Cool Path Duo flow rate is equivalent to that of a six-outlet port irrigated catheter.

All Cool Path catheters have ergonomic handles designed for manoeuverability, and proprietary shafts that give physicians flexibility and resiliency, as well as torque for electrode placement and consistent response.

The new integrated components will be launched in markets outside the USA early this year.


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