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St. Jude Medical Receives Approvals to Bring State-of-the-Art ICD Technology to Japan; New Releases Signal Company's First Entry into Japanese High-Voltage Market
Business Wire, Sept 1, 2005
ST. PAUL, Minn. & TOKYO, Japan -- St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory and reimbursement approvals from the Ministry of Health, Labor and Welfare in Japan for the Epic(TM) and Atlas(R) implantable cardioverter defibrillator (ICD) product families. The devices are the first St. Jude Medical(R) ICDs available in Japan.
"We are pleased to introduce the premiere Epic and Atlas ICD families to Japan," said Paul Bond, President, Getz Brothers Co., Ltd., a St. Jude Medical Company. "Physicians will appreciate the ways they can improve patient care with this advanced technology, and ICD patients will appreciate the comfort made possible by the compact size of the devices."
In addition to Getz Brothers Co., Ltd., the ICDs will be immediately available in Japan through Fukuda Denshi Co., Ltd.
"Japan represents the world's second largest medical technology market, with ICD implants growing at a rate of 20-30% annually over the past few years," said Joseph H. McCullough, President of St. Jude Medical International. "Today's introduction opens this market to St. Jude Medical and establishes important new ICD therapy options for patients in Japan."
Engineered to anticipate a wide variety of diagnostic and therapy needs of ICD patients, the devices are also designed to make it easier for physicians to manage patients with atrial fibrillation (AF). AF is the world's most common cardiac arrhythmia that results in a very fast, uncontrolled heart rhythm caused when the upper chambers of the heart (atria) quiver instead of beating.
The Epic(TM) and Atlas(R) ICD families bring together many of St. Jude Medical's innovative technologies, including:
--The AF Suppression(TM) algorithm, which provides the only clinically proven technology to suppress episodes of atrial fibrillation; and
--AutoSensitivity Control, morphology discrimination (MD) and A-V rate branch, which are designed to help avoid unnecessary shocks and promote fast diagnosis and therapy with precise, patient-specific supraventricular tachycardia (SVT) discrimination.
The Epic(TM) ICD is the smallest device available in Japan capable of delivering a clinically important 30 joules of energy. The Atlas(R) ICD is the most powerful device available in Japan, providing up to 36 joules of delivered energy.
ICDs are medical devices implanted under the skin that are designed to deliver a range of electrical therapies, from mild stimulation to more powerful shocks, to treat patients with ventricular tachycardia (VT) and ventricular fibrillation (VF). These potentially lethal heart rhythms commonly contribute to sudden cardiac death.
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.
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