Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - February 5, 2008

St. Jude Medical Announces European CE Mark Approval of Integrated Irrigation Pump and Cardiac Ablation Generator

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced 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, Inc., 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. It 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 150 watts 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 excellent maneuverability, 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 United States early this year.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.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 Company’s Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). 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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