Healthcare Industry News:  neuromodulation 

Devices Cardiology

 News Release - January 15, 2009

St. Jude Medical Announces First Use Outside the U.S. of Imaging System for Real-Time Views inside the Heart

System provides greater physician control during therapeutic and diagnostic procedures

ST. PAUL, MN, Jan 15, 2009--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the first use outside the United States of its ultrasound imaging system that enables physicians to view real-time images from inside the heart as they diagnose and treat conditions resulting from abnormal rhythms or structural problems. By providing clear, accurate images of the heart’s interior anatomy and the position of devices, the system enables physicians to perform procedures with increased control.

The ViewMate(TM) II Ultrasound System with the ViewFlex(TM) PLUS Intracardiac Echocardiography (ICE) Catheter is one of many St. Jude Medical products featured this week at the Boston Atrial Fibrillation Symposium, which begins today and will be ongoing through Jan. 17 in Boston.

The ViewMate system uses ultrasound technology to produce high-resolution intracardiac (inside the heart) images. The system transmits high-frequency sound waves through a transducer on the tip of the catheter – the transducer converts electric energy into sound energy, the sound waves then reflect off structures inside the heart and the transducer converts them back into electric energy to produce the anatomical images.

The intracardiac images created by the ViewMate II System help guide physicians in performing procedures such as radiofrequency (RF) ablation to treat irregular heart rhythms, including atrial fibrillation (AF), and in closing defects such as patent foramen ovale (PFO), a small hole or opening in the wall between the two upper chambers of the heart (the atria). Clear views inside the heart also help reduce the time that it takes physicians to perform procedures, enabling patients to recover more quickly and enhancing hospital productivity.

The ViewMate II System with the ViewFlex PLUS Catheter recently received European CE Mark approval. The system also received U.S. Food and Drug Administration (FDA) clearance in January 2008 and has been used in the U.S. since that time. St. Jude Medical began marketing and distributing the ViewMate II System with ViewFlex PLUS Catheter following its merger with EP MedSystems, Inc. in July 2008.

Yaariv Khaykin, M.D., and Atul Verma, M.D., from Southlake Regional Health Centre in Newmarket, Ontario, Canada, performed the first procedures using the ViewMate System outside the United States. “The ViewMate System provides images of improved contrast. Sharper, clearer images are critical to accurate diagnoses and precise treatments,” said Dr. Khaykin. Dr. Verma added, “The ViewMate System enables me to obtain images with greater depth, which in turn allows for more informed diagnoses and treatment decisions.”

The ViewFlex PLUS catheter’s one-hand control frees physicians to simultaneously position other devices with the other hand. Its tip features a 64-element, linear-phased array transducer capable of detailed, high-resolution imaging. The tip itself has a bidirectional curve and a deflection angle of up to 120 degrees, allowing it to capture images across broad areas of the heart. The catheter’s 9 French size allows physicians to create a smaller opening through which to insert the catheter into a vessel, yet its design provides stability and control over viewing angles and positioning.

“The first use of the ViewMate II System outside the U.S. marks a significant milestone as we introduce products that help physicians around the world treat atrial arrhythmias, including AF, a heart condition that affects millions of people and will grow in prevalence as populations age,” said Jane J. Song, president of the St. Jude Medical Atrial Fibrillation Division. “St. Jude Medical is committed to providing wide distribution of this and other technologies that increase physician control during the treatment of AF and other interventional cardiac procedures.”

The ViewMate II ultrasound console is a complete digital cardiovascular imaging system. It provides transesophageal (through the esophagus) and transthoracic (from outside the body), as well as intracardiac, imaging capabilities, and thus enables hospitals to maximize the value of their equipment investments. The console features on-screen menus and displays designed for intuitive operation by clinicians. Its monitor and keyboard are easily adjusted for comfortable viewing. In addition, the console is able to store ultrasound digital images and files, allowing physicians to gain quick access to them as needed.

St. Jude Medical and Philips Healthcare Agreement

The ViewMate II ultrasound console is manufactured by Philips Healthcare, a leader in ultrasound technology, and is based on the Philips HD11 XE platform. Under an agreement with Philips Healthcare, St. Jude Medical distributes the ViewMate II console as a stand-alone product and as part of the ViewMate II System.

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. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. 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 Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. 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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