Healthcare Industry News: atrial flutter
News Release - June 1, 2006
St. Jude Medical Announces Japanese Approvals of EnSite System
Computer-based Visualization and Navigation Tool Used with Heart Rhythm PatientsST. PAUL, Minn.--(HSMN NewsFeed)--June 1, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced regulatory and reimbursement approvals from Japan's Ministry of Health, Labor and Welfare for the EnSite® System in Japan. The EnSite System is a computer-based visualization and navigation tool used by physicians when treating patients with irregular heartbeats.
The EnSite System allows electrophysiologists (physicians who practice a sub-specialty of cardiology) to create computer-generated, three-dimensional models of their patients' cardiac anatomy. After collecting and organizing electrical signal data from the inner surface of the heart, the system shows the location and movement of abnormal electrical impulses, helping physicians determine a treatment strategy. These enhanced images were not possible with the older, two-dimensional fluoroscopy (moving X-ray).
"The EnSite System is the most advanced computer-based technology for mapping arrhythmias and navigating electrophysiology catheters in real time," said Kazuo Ogino, president and CEO for Nihon Kohden, St. Jude Medical's EnSite System distributor in Japan. "Since market approval, the EnSite System has been used at leading facilities in Japan, including Tsuchiura Kyodo, Yokohama Minato Red Cross, Kumamoto University, Nara Medical University, University of the Ryukyus and others. This clearly indicates strong clinical utilization by Japanese doctors."
In the first procedures performed in Japan, electrophysiologists used the EnSite System and the EnSite Array(TM) non-contact catheter to diagnose and guide ablation therapy of patients with atypical atrial flutters and atrial fibrillation (AF).
"The introduction of EnSite in Japan will help physicians provide greater clinical value for Japanese patients by accurately diagnosing the origin of arrhythmias quickly and safely," said Joseph H. McCullough, president of St. Jude Medical's International Division. "These capabilities are a critical element of effective electrophysiology procedures."
After heart failure, atrial fibrillation is the most prevalent, debilitating and expensive cardiovascular disease, affecting more than 6 million patients worldwide. It is a pervasive cardiac rhythm disorder in which the upper chambers of the heart do not beat effectively, resulting in reduced cardiac output. This exacerbates heart failure and can result in the pooling and clotting of blood in the heart, which may lead to stroke or other neurological problems. With age, AF becomes more severe and more common.
St. Jude Medical's initiatives are aimed at finding treatments that can help cure an increasing number of atrial fibrillation patients, including developing new technologies, procedures and clinical studies that will result in reproducible and economically-sound treatment options. Currently, St. Jude Medical provides electrophysiologists with products for site access, diagnosis, visualization and ablation therapy.
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 10,000 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 success, regulatory approvals, anticipated future product launches, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). 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
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
