St. Jude Medical Introduces Ultra-Thin ICD Lead Family to Japanese Market
October 04 2005 - 9:54AM
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 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.
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