Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - June 17, 2010

St. Jude Medical Announces European Approval of EnSite Contact Technology Platform

New technology designed to offer physicians objective, real-time measurements to better determine catheter tip-to-tissue contact during ablation procedures

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced European CE Mark approval of the EnSite Contact™ Technology platform at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim). The new proprietary EnSite Contact Technology is a diagnostic system of unique ablation catheters, a hardware module, and specially designed software that measures, analyzes and displays electrical coupling (also known as electrical contact) to determine the level of contact the ablation catheter’s tip has with endocardial tissue during cardiac ablation therapy procedures.

Cardiac ablation procedures are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart’s ability to effectively pump blood to the body. The quality of ablation catheter tip-to-tissue electrical contact is an important factor in the delivery of radiofrequency (RF) energy during catheter ablation. Measuring how well the RF energy needed for cardiac ablation is electrically coupled between the catheter tip and the tissue can help improve physicians’ control over catheter position during ablation procedures. It also has the potential to make the procedure more efficient by reducing the need for touching up lesions.

The EnSite Contact Technology works with both the EnSite System and the EnSite Velocity System, and conveniently displays information regarding the amount of contact the ablation catheter has with the endocardial surface on the system screen. It was designed to be used with the Contact Therapy™ Cool Path ™ Duo Ablation Catheter as well as other irrigated ablation catheters currently in development. Using an irrigated catheter to cool the tip helps to reduce some of the risk factors associated with the heat of the RF energy, such as blood coagulation, charring and steam popping.

“The quality of catheter contact is critical to ensure ablation efficiency and safety, and EnSite Contact Technology helps me ensure optimal contact while delivering ablation therapy,” said Dr. Christopher Piorkowski, Department of Electrophysiology at the University of Leipzig – Herzzentrum in Leipzig, Germany. “The objective values provided by EnSite Contact Technology help me to determine the level of electrical coupling, which is important to understanding the contact of the catheter tip to the heart surface, one of the most significant information deficits we have in EP ablation cases today.”

To understand the contact between the ablation catheter tip and endocardial tissue, electrophysiologists have previously been limited to qualitative techniques such as tactile feedback, fluoroscopic imaging and ablation generator impedance. The EnSite Contact Technology addresses the limitations in these techniques by establishing a quantitative, real-time and reproducible measurement of tip-to-tissue electrical contact.

“St. Jude Medical leads the way in developing innovative technologies designed to improve the safety and efficacy of catheter ablation,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “Our EnSite Contact Technology is another example of the many technology platforms in which St. Jude Medical is delivering on its promise to put more control in the hands of physicians.”

Cardiac ablation catheters are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart’s ability to effectively pump blood to the body. Ablation catheters are thin, flexible tubes that non-invasively deliver RF energy to specific areas of cardiac tissue in order to create lesions, or tiny scars, that interrupt the abnormal electrical signals that contribute to irregular heart rhythms.

The EnSite Contact Technology platform is not currently available in the United States.

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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. 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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