St. Jude Medical Receives Approvals to Bring State-of-the-Art ICD Technology to Japan; New Releases Signal Company's First Entry
September 01 2005 - 4:30PM
Business Wire
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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