Healthcare Industry News:  chronic pain 

Devices Cardiology Regulatory

 News Release - June 18, 2010

St. Jude Medical Announces European Approval of Industry's First Flexible Tip Ablation Catheter

The Therapy Cool Flex is the Industry’s First Ablation Catheter with a Fully-Irrigated, Flexible, Laser-Cut Tip Which Conforms to Cardiac Anatomy

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced European CE Mark approval of the Therapy™ Cool Flex™ Ablation Catheter at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim). The ablation catheter is the industry’s first to have a fully-irrigated and flexible tip, which can potentially improve the safety and efficacy of cardiac ablation procedures.

Cardiac ablation catheters, such as the Therapy Cool Flex Ablation Catheter, are used to help treat cardiac arrhythmias, which are irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. Catheters are thin flexible tubes that deliver 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.

The innovative design of the Therapy Cool Flex Ablation Catheter features a flexible, laser-cut tip which can bend to conform to the cardiac anatomy. In addition to this flexibility, the laser cut design allows fluid to be infused around the entire catheter tip electrode (the part of the catheter that delivers the RF energy.) Together, these new features have been designed to allow for unmatched catheter tip cooling and increase the ability of the catheter to stay in contact with the endocardial surface.

Reflecting on his experience with the Therapy Cool Flex, Carlo Pappone M.D., PhD and Director of Arrhythmology at Villa Maria Cecilia Hospital in Cotignola, Italy remarked, “I found the Therapy Cool Flex tip to be capable of flexion upon the tissue, which in turn engages a larger surface area. This and other unique features help to improve contact stability and optimize energy transfer to the tissue while reducing catheter induced mechanical stress.”

Compared to catheters with rigid tip design, the Therapy Cool Flex catheter tip has been designed with the intention to conform better to a greater range of cardiac tissue anatomy using various angles of approach, which can make the delivery of therapy more effective. The coil spring-loaded flexible tip can conform to the contours of the tissue up to 20 degrees when in contact with the endocardial surface.

The unique, laser-cut tip electrode of the Therapy Cool Flex catheter was designed to provide optimal irrigation flow over the entire tip electrode for improved cooling compared to conventional irrigated catheter designs. The catheter electrode features irrigation slits arranged in a zig-zag pattern and four ports at the distal end of the tip to allow irrigation to flow around the entire surface area of the tip. Additionally, the effect of the catheter tip bending and conforming to the tissue opens the irrigation slits on the side of the catheter tip facing the tissue, directing saline flow to the area where it is most needed – the interface where the catheter tip meets the tissue. The improved cooling capabilities may help to reduce some of the risk factors associated with the delivery of the RF energy, such as blood coagulation, charring and steam popping.

“The Cool Flex has an advanced design that can bend and flex to conform to the cardiac anatomy and gives me more control throughout an ablation procedure,” said Dr. Pierre Jais of Hôpital Cardiologique Haut-Leveque in Bordeaux-Pessac, France.

Commenting on the CE Mark approval of the Therapy Cool Flex Ablation Catheter, Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division said, “St. Jude Medical has developed a very special and unique treatment solution for physicians with the Therapy Cool Flex Ablation Catheter. We believe that our flexible tip has a strong potential to replace a rigid tip as the new industry standard for irrigated catheter ablation. It is one of several potentially game-changing products that we look forward to bringing to market soon.”

The Therapy Cool Flex 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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