St. Jude Medical Announces FDA Approval of the OptiSense(TM) Pacing Lead
May 09 2007 - 8:30AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) approval of its new OptiSenseTM lead, a
first-of-its-kind �smart� pacing lead designed to offer more
accurate sensing in the upper chamber of the heart (right atrium).
The lead incorporates a new tip design that reduces extraneous
signals from the heart�s lower chambers (ventricles) that can
interfere with a pacemaker�s sensing mechanism and disrupt optimal
therapy. The OptiSense lead�s improved sensing of desired
electrical signals in the atria allows physicians more flexibility
in programming atrial sensitivity settings while avoiding sensing
signals from the ventricles. This allows for more accurate
detection of impulses from the patient�s atrium. In the past,
physicians sometimes had to program a pacemaker to be less
sensitive to avoid the detection of interfering signals. However,
while decreasing the sensitivity settings helps to reduce the
interfering signals, it can also reduce the sensing of important
signals, like the small signals that can occur during atrial
arrhythmias. More sensitive atrial sensitivity settings are,
therefore, especially important in patients with atrial
tachyarrythmias (an abnormally fast heart rate), such as atrial
fibrillation. By reducing the detection of unwanted signals, the
OptiSense lead may also provide physicians greater freedom in lead
placement options. Now, leads may be able to be placed in areas,
such as the lower inner atrium, that may be optimal for pacing, but
that may have previously been ruled out because of interfering
signals from the heart�s lower chambers. A lead is an insulated
wire that is placed through the vein as part of a pacemaker
implantation procedure. Its tip is attached to the heart tissue,
while its other end connects to the pacemaker. A lead carries
electrical impulses from the implanted device to the heart and
transmits information from the heart back to the implanted device.
The improved sensing performance of the OptiSense lead is a result
of an innovative 1.1 mm tip-to-ring spacing, which reduces
oversensing of far-field R-wave signals (an electrical signal
originating in the lower chamber of the heart and sensed by the
lead in the upper chamber of the heart). The conclusions reached by
the OptiSense Lead Clinical Study (the results of which will be
presented on May 9 at 5:45 p.m. Mountain time during the Featured
Poster Session at the Heart Rhythm 2007 meeting) include the
following: The OptiSense lead had no evidence of paced far-field
signals in 90.9 percent of patients compared to 40.9 percent of the
control patients (p < 0.0001). The OptiSense lead group
exhibited a highly statistically significant reduction (p = 0.03)
in the percentage of patients with inappropriate mode switching
(6.9 percent of OptiSense patients versus 25.7 percent of control
group patients) as well as a highly statistically significant
reduction (p = 0.009) in the percentage of episodes of
inappropriate mode switching (3 percent versus 49 percent).
Inappropriate mode switching is not desirable because, if it
occurs, it can cause a loss of synchrony between the upper and
lower chambers of the heart. �The innovative design of the
OptiSense lead offers significant advantages for both physicians
and patients,� said Michael J. Coyle, president of St. Jude
Medical's Cardiac Rhythm Management Division. �These new features
enhance pacemaker function, support physician preferences to pace
more physiologically and provide better therapies for patients.�
Heart Rhythm 2007 is the most comprehensive educational program for
heart rhythm professionals, featuring over 200 educational sections
and more than 130 innovative products and services. This year, the
meeting will open with the AFib Summit, a two-day intensive summit
on atrial fibrillation featuring world-renowned experts. The Heart
Rhythm Society�s Annual Scientific Sessions have become the
must-attend event of the year, allowing the exchange of new vital
ideas and information among colleagues from every corner of the
globe. About St. Jude Medical St. Jude Medical is dedicated to
making life better for cardiac, neurological and chronic pain
patients worldwide through excellence in medical device technology
and services. The Company has five major focus areas that include:
cardiac rhythm management, atrial fibrillation, cardiac surgery,
cardiology and neuromodulation.�Headquartered in St. Paul, Minn.,
St. Jude Medical employs more than 11,000 people worldwide. For
more information, please visit www.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 Company�s Annual Report on Form 10-K filed on February 28, 2007
(see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the
Company�s Form 10-K). 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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