Healthcare Industry News:  Cool Path 

Devices Cardiology Regulatory

 News Release - June 24, 2010

St. Jude Medical Announces Japanese Approval of the Therapy Cool Path Ablation Catheter

The Therapy Cool Path is the company’s first irrigated ablation catheter in Japan

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced Japanese Ministry of Health, Labour and Welfare (MHLW) approval and reimbursement approval of its Therapy™ Cool Path™ Ablation Catheter. This marks the company’s first entry into the irrigated catheter ablation market in Japan.

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. The Therapy Cool Path Ablation Catheter is a thin, flexible tube that delivers radiofrequency (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.

Irrigated catheters, such as the Therapy Cool Path, are designed to cool the ablation electrode with the intent of reducing some of the risk factors associated with the heat of the RF energy, such as blood coagulation and charring as the amount of energy required to create an effective cardiac lesion must be carefully balanced against tissue temperature. Additionally, irrigation is designed to allow for the creation of larger and deeper lesions, because the saline fluid from the catheter helps to cool the catheter tip and tissue. The larger and deeper legions help to stop the arrhythmia at its source, which can be deep within the heart muscle by treating the area causing the abnormal heart rhythm.

“I believe that catheter ablation is an essential therapy to treat any cardiac arrhythmia. In my experience, the Cool Path ablation system has a unique irrigation function that helps control the temperature, which remarkably improves the effectiveness and safety of ablation and I believe will expand the application of ablation therapy,” said Yoshito Iesaka, MD, Deputy Director, Tsuchiura Kyodo General Hospital.

“With research continuing to demonstrate that ablation is safe and effective therapy for the treatment of cardiac arrhythmias, we are pleased to offer advanced ablation technology to the Japanese market,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “The Therapy Cool Path ablation catheter is the first of many product and technology launches that will put more control in the hands of physicians.”

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

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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