St. Jude Medical Announces European Launch of USB Cellular Adaptor for Merlin@Home Transmitter
February 10 2010 - 1:30AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced European CE
Mark approval of its USB cellular adaptor for the Merlin@home™
transmitter, a system that allows important patient data from an
implantable cardiac device to be wirelessly downloaded and securely
transmitted via telephone for review by a physician. The new USB
adaptor allows patients using a Merlin@home transmitter to transfer
data to their physician over the cellular network, in addition to
the existing landline service previously available.
“The USB cellular adaptor allows patients who frequently travel
or relocate to be free of the restrictions of a traditional
telephone line,” said Dr. Helen Høgh Petersen, of Rigshospitalet in
Copenhagen, Denmark. “This addition to the remote monitoring system
helps to ensure that patients can stay connected with their device
follow-up clinic wherever they may live or travel.”
The USB cellular adaptor is a small device that plugs into new
and existing Merlin@home transmitters. The transmitter typically
sits on a patient’s bedside table and wirelessly communicates with
the patient’s device during the night. Regularly scheduled
follow-up appointments and daily device checks occur without any
patient interaction required. This connectivity allows patients to
limit the need for unnecessary visits to their physician’s office,
but also allows physicians to more quickly become aware of any
changes with the patient’s condition or device.
The Merlin@home transmitter is transportable and can transmit
device data from anywhere with a mobile signal or landline and
electrical power. The transmitter supports all radio-frequency (RF)
St. Jude Medical implantable cardioverter defibrillators (ICDs) and
cardiac resynchronization therapy defibrillators (CRT-Ds), and the
Accent™ RF pacemaker and Anthem™ RF CRT-P (cardiac
resynchronization therapy pacemaker). The Accent RF pacemaker and
Anthem CRT-P are the first and only pacemakers that provide
complete remote and in-clinic follow-ups via wireless
communication. The data from these devices are transmitted from the
patient to the physician via the Merlin.net™ Patient Care Network
(PCN), an Internet-based repository of patient and device data.
The need for data communication over the cellular network is
particularly significant in Europe. According to a 2008
Eurobarometer E-communications Household Survey, nearly a quarter
(24%) of all European households had only mobile phone access, and
the mobile-only rate was even higher in the 12 newest European
Union Member States (39%).
“The USB Cellular Adapter expands the global reach of the
Merlin.net PCN to new markets, particularly those markets that rely
heavily on cellular technology,” said Eric S. Fain, M.D., president
of the St. Jude Medical Cardiac Rhythm Management Division. “This
technology provides a reliable, secure transmission option that
allows both patients and clinicians to experience the value of
connectivity.”
Implantable cardiac devices are designed to capture and record
information about device performance and patient heart rhythms that
is vital to patient care. Merlin.net PCN organizes this information
for fast analysis and easy review and allows data to be sent
directly to a clinic's or a hospital's EHR system so the data can
be included in the patient’s comprehensive personal health record.
Alerts can also be set up by the physician, based on their
preferences, notifying them of any urgent changes with the
patient’s condition or device.
The data transferred using the Merlin@home device is fully
encrypted and meets or exceeds all applicable national data privacy
and security requirements in every country where we use the
Merlin.net PCN. In addition, BSI Management Systems, an
international standards, testing, registration and certification
organization, has awarded St. Jude Medical the information security
certification ISO/IEC 27001:2005. This ISO certification, a
stringent worldwide information security standard, recognizes that
St. Jude Medical’s Merlin.net PCN has established processes and
standards that maintain the strictest levels of confidentiality,
integrity and availability for its customers. The Merlin.net PCN is
the first medical device data network to be recognized with this
certification.
The Merlin.net PCN was also recognized as a silver winner of the
2009 Medical Design Excellence Awards, an award competition that is
organized and presented by Canon Communications LLC and is the only
awards program that exclusively recognizes contributions and
advances in the design of medical products.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. Headquartered in St. Paul, Minn., St.
Jude Medical employs more than 14,000 people worldwide and has four
major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more
information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Quarterly Reports on Form 10-Q for the fiscal quarters
ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company
does not intend to update these statements and undertakes no duty
to any person to provide any such update under any
circumstance.
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