St. Jude Medical Announces FDA Approval of New Housecall Plus(TM) System Software Designed to Advance Remote Patient Monitoring
July 07 2005 - 4:05PM
Business Wire
In an effort to provide important new communications benefits to
medical professionals who remotely monitor implantable cardioverter
defibrillator (ICD) patients, St. Jude Medical, Inc. (NYSE:STJ)
announced today it has received U.S. Food and Drug Administration
(FDA) approval of its version 2.1 software upgrade for the
Housecall Plus(TM) remote patient monitoring system. This upgrade
enables medical professionals to create electronic PDF (portable
document format) files of patient's device interrogation results
and either transmit them electronically or post them on a secure
Web site for further review by physicians. The upgrade also expands
in-office networking capabilities, extending St. Jude Medical's
leadership in remote monitoring technology. "With the number of ICD
patients expected to expand significantly over the next few years,
physicians face an enormous challenge in managing regular follow-up
visits for those patients," said Michael J. Coyle, President of St.
Jude Medical's Cardiac Rhythm Management Division. "The version 2.1
software upgrade offers physicians even greater flexibility to
provide excellent follow-up care more efficiently when using the
Housecall Plus system." The Housecall Plus(TM) system offers live
communication with a medical professional, and is the world's first
remote patient monitoring system to transmit complex ICD data in
real time over standard telephone lines for immediate review. The
complete diagnostics available in the system provide real-time
electrograms, surface ECGs, signals and settings of the ICD,
delivered therapies and stored electrograms. Remote monitoring
simplifies follow-up visits for all patients, but it is especially
important for housebound patients or those who live in isolated
areas. While the system does not eliminate the need for doctor
visits, it offers important insights into when a patient should be
seen. Costs associated with unnecessary office and emergency room
visits may also be reduced. A survey of patients currently using
the system indicated a very high satisfaction with the convenience
of transmitting from home versus driving to a clinic. The Housecall
Plus(TM) remote monitoring system supports St. Jude Medical's
Atlas(R) and Epic(TM) families of ICD and cardiac resynchronization
therapy (CRT) devices. Future St. Jude Medical ICDs and pacemakers
will also function with the system. 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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