New monitor helps physicians detect abnormal heart rhythms in
patients with unexplained symptoms
ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 11, 2008--St. Jude
Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug
Administration (FDA) clearance of its SJM Confirm(TM) implantable
cardiac monitor (ICM), a compact device designed to help physicians
diagnose abnormal heart rhythms.
The implantable monitor enables physicians to evaluate heart
rhythm signals over a longer period of time than allowed by standard
monitoring tests, and is designed to help them diagnose and document
difficult-to-detect rhythm disorders in patients who may suffer from
unexplained symptoms, including syncope (the sudden and transient loss
of consciousness), palpitations and shortness of breath.
About the size of a computer thumb drive, the SJM Confirm ICM is
the smallest implantable cardiac monitor available. It is implanted
just under the skin (subcutaneously) in the upper chest region and can
be implanted in an outpatient procedure under local anesthesia.
Patients are able to remotely send data to their physicians when they
experience symptoms. This real-time data helps physicians diagnose and
treat the arrhythmias.
The SJM Confirm ICM features a St. Jude Medical sensing algorithm
designed to enhance signal detection, thus enabling physicians to
program the device to be more sensitive to small and wide-ranging
signals. Electrodes on the monitor sense cardiac activity and a
continuous loop recorder stores information about the heart's
activity. The electrodes are positioned on opposite sides of the
device; this design is intended to provide better contact with the
subcutaneous tissue for more accurate sensing of cardiac signals.
Syncope is responsible for about 3 percent of all emergency room
visits and up to 6 percent of all hospitalizations. About 1 million
people in the U.S. suffer from syncope, and the source of unexplained
syncope, according to some physicians, is the most difficult diagnosis
to make. Even after a physical examination and electrocardiogram (ECG)
evaluation through a Holter monitor, approximately half of all cases
of unexplained syncope go undiagnosed.
"The SJM Confirm ICM was developed in response to physicians' need
for more information about heart rhythm abnormalities, particularly in
patients who are most challenging to diagnose," said Eric S. Fain,
M.D., president of the St. Jude Medical Cardiac Rhythm Management
Division. "This implantable monitor enables patients to record data
that coincide with their symptoms and then send that data to their
physicians remotely for diagnosis and determination of the best course
of treatment for their arrhythmias."
The SJM Confirm ICM is the first implantable monitor to be built
on a unified platform, which has enabled St. Jude Medical to more
quickly introduce devices with new features and diagnostics (as they
become available) because the basic platform for all of the devices is
the same. The St. Jude Medical "Unity" device platform first was
introduced in September 2007 with the launch of its Promote(R) RF
CRT-D and the Current(R) RF ICD devices. Due to its uniform software
interfaces and expanded features, the new platform gives physicians
more choices during device programming and patient follow-up.
The SJM Confirm ICM also features:
- Programmable event triggers, which enable physicians to
program the device to automatically capture and record up to
60 seconds before and after a cardiac event
- Three year device longevity
- Compatibility with the St. Jude Medical(R) Merlin(R) Patient
Care System, a powerful, portable computer designed to help
physicians access and analyze diagnostic information and print
full-size comprehensive data reports
- Remote monitoring that allows patients to send data directly
to their physicians
The SJM Confirm ICM will be launched in October 2008.
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 12,500 people worldwide and has five major focus areas that
include: cardiac rhythm management, atrial fibrillation, cardiac
surgery, cardiology and neuromodulation. For more information, please
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 Annual
Report on Form 10-K filed on February 27, 2008. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.
CONTACT: St. Jude Medical, Inc.
Angela Craig, 651-481-7789
Kathleen Janasz, 651-415-7042
SOURCE: St. Jude Medical, Inc.