St. Jude Medical Announces FDA Clearance and European Approvals for Cardiac Mapping and Navigation Software
May 08 2007 - 2:00PM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) clearance and European CE Mark for the
EnSiteTM System Version 7 software, and European CE Mark of the
EnSite FusionTM Registration Module. The new products will help
physicians create more detailed images of the heart for navigating
during electrophysiology (EP) procedures that treat complex
arrhythmias. The EnSite System provides highly detailed,
three-dimensional (3-D) cardiac models that help physicians
diagnose and treat many abnormal heart rhythms, including atrial
fibrillation. Superior imaging results in better, faster care for
patients and more reliable diagnostic tools for physicians. St.
Jude Medical�s EnSite Fusion software registers, or �fuses,� an
EnSite-created geometry model with a three-dimensional CT (computed
tomography, the current gold standard) model so that the physician
can map directly on the CT image. The result is a 3-D, color,
highly-detailed image of a chamber of the heart in which physicians
can navigate EP catheters, display electrical information and
effectively guide therapy delivery. EnSite Fusion allows physicians
to use one system � EnSite � to produce state-of-the art imagery.
EnSite Fusion is the first and only registration tool with the
capability to perform �dynamic registration.� Dynamic registration
matches the two models by creating anchor points on the EnSite
images which are then linked to points on the 3-D model of the
patient�s CT. Fusing the geometric- and CT-derived models gives
physicians a more detailed image of the heart to help them deliver
ablation therapy. The new Version 7 software�s �field scaling�
feature allows the system to compensate for impedance variations
and improve the visualization of the heart�s anatomy and EP
catheters. EnSite 7 also includes new measurement tools which
provide additional information about the size and location of key
structures in the heart. Its detailed cardiac geometry gives
physicians more data than ever before. Carlo Pappone, M.D., Ph.D.,
of San Raffaele University Hospital in Milan, Italy, said, �This
new software helps me create detailed, high-quality 3-D models of
the heart�s anatomy in just a few minutes, which greatly improves
procedure efficacy and reduces the need for remote catheter
manipulation.� The fusion tool also displays electrical information
such as voltage, activation timing and lesion data directly on the
CT model. In addition, EnSite Fusion provides the flexibility to
transition quickly between the fused model and the original EnSite
model throughout the procedure, helping clinicians react to changes
in patient anatomy or other variations. �EnSite Fusion makes the
image even more realistic and provides an extremely detailed
picture of the heart�s anatomy,� said Richard Schilling, M.D., of
St. Bartholomew's Hospital in London. �I now can have a better
diagnostic tool because two images � a CT image and the cardiac
mapping image � are fused into one. Because everybody�s heart is
different, accuracy and precision are essential in diagnosis and
treatment.� St. Jude Medical will feature EnSite� System Version 7
and the EnSite Fusion� Registration Module at the 2007 Heart Rhythm
Society meeting in Denver, Colo., on May 9 through 12. 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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