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St. Jude Medical Introduces Ultra-Thin ICD Lead Family to Japanese Market

Posted on: Tuesday, 4 October 2005, 12:02 CDT

St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for the Riata(TM) family of implantable cardioverter defibrillator (ICD) leads. The highly advanced leads, with diameters as small as 6.7 French, rank among the world's thinnest. They are the first St. Jude Medical(R) high-voltage leads available in Japan.

"Riata leads provide an excellent complement to the premiere Epic+ and Atlas+ ICD families introduced in Japan last month," said Paul Bond, President, Getz Brothers Co., Ltd., a St. Jude Medical Company. "We expect that physicians will respond to the leads quickly and enthusiastically because they combine the highest level of performance with remarkable thinness."

In addition to Getz Brothers Co., Ltd., the leads will also be available in Japan through Fukuda Denshi Co., Ltd.

"We are pleased to expand our high-voltage product offerings in Japan with these state-of-the-art leads," said Joseph H. McCullough, President of St. Jude Medical International. "The ultra-small size of Riata leads is designed to allow physicians to navigate more easily through difficult cardiac anatomies and place the lead more precisely to improve the benefits of therapy for ICD patients."

Beyond the small diameter, Riata(TM) leads feature silicone body insulation, titanium tip housing with radiopaque markers for better visibility under fluoroscopy, Fast-Pass(TM) coating for easier placement, and steroid-elution designed to minimize inflammation and promote low-pacing thresholds.

ICD leads come in many variations (true bipolar, single-coil, dual-coil, active and passive fixation, as well as multiple lengths) to provide a broad range of products to meet the requirements of individual patients and physicians. Many physicians develop strong and specific preferences for certain types of leads. Other physicians may prefer a certain type of lead in most cases, but like the option of alternate configurations for special cases. For that reason, offering a wide range of lead options - such as the St. Jude Medical Riata(R) lead family - is important in the market.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (known as ventricular tachycardia or ventricular fibrillation) by delivering energy to the heart through an insulated wire or lead. Defibrillation leads also have the ability to sense disruptions to a patient's heartbeat, and transmit these impulses back to the ICD to determine whether the potentially life-saving therapy should be delivered. Within the heart, the defibrillation lead contains one or two electrical coils, depending on physician preference. Electrical energy forms a circuit from the coil or coils to the ICD and back to the heart.

St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.

Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.

Source: Business Wire

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