| Paris, France – November 15, 2004
– IBM and Dassault Systèmes (Nasdaq: DASTY; Euronext
Paris: #13065, DSY.PA) today announced that superDimension
Ltd., a medical equipment manufacturer that specializes
in minimally invasive diagnosis and treatment of lung
disease via CT-guided bronchoscopy, has developed and
received US Food & Drug Administration (FDA) approval
of its superDimension™/Bronchus system using their Product
Lifecycle Management (PLM) technology.
IBM PLM Solutions, with SMARTEAM for collaborative
product data and lifecycle management developed by Dassault
Systèmes, have enabled superDimension to develop and deliver
a real-time minimally invasive lung navigation system
an estimated 30% faster than originally planned. The innovative
medical device, the superDimension/Bronchus system, improves
the success rate in diagnosing and treating lung cancer
and other lung diseases via CT-guided bronchoscopy by
enabling access to the peripheral areas of the lungs in
a minimally invasive manner.
superDimension used SMARTEAM’s regulatory approval
template to speed superDimension/Bronchus through regulatory
approvals, in this case, the U.S. government’s Food and
Drug Administration (FDA) certified Code of Federal Regulations
(CFR) 21 Part 11. The template feature stores thousands
of pages of superDimension’s design reviews, market data
and engineering data in an easily searchable, organized,
secure, and audited structured platform with electronic
signatures for accountability.
“Using SMARTEAM, the cycle time at superDimension for
developing superDimension/Bronchus was reduced dramatically,
and we expect even more time-savings once we start production
and begin outsourcing components,” said David Tolkowsky,
president and CEO of superDimension. “PLM technology has
helped us develop a tool that was affordable and could
be delivered very rapidly.”
“In addition to data management, SMARTEAM was also
used to create a complex workflow for engineering change
orders and change requests in the development of the Bronchus
System,” said Denis Senpéré, vice president PLM Europe,
Dassault Systèmes. ”Using SMARTEAM for the entire process,
changes are quicker, more accurate, paperless, and can
easily be updated and accessed online.”
superDimension/Bronchus has also received the CE Mark
approval, which indicates that a product complies with
the essential requirements of European laws, and has successfully
completed clinical trials in Germany and Israel.
About Dassault Systèmes
As world leader in PLM (Product Lifecycle Management)
solutions, the Dassault Systèmes group brings value to
more than 70,000 customers in 80 countries. A pioneer
in the 3D software market since 1981, Dassault Systèmes
develops and markets PLM application software and services
that support industrial processes and provide a 3D vision
of the entire life cycle of products from conception to
retirement. Its offering includes integrated PLM solutions
for product development (CATIA®, DELMIA®, ENOVIA®, SMARTEAM®),
mainstream product design tools (SolidWorks®), and 3D
components (ACIS®) from Spatial Corp. Dassault Systèmes
is listed on the Nasdaq (DASTY) and Euronext Paris (#13065,
DSY.PA) stock exchanges.
For more information, visit
http://www.3ds.com
About IBM
IBM is the world's largest information technology company,
with 80 years of leadership in helping businesses innovate.
IBM Sales & Distribution, which supports more than a dozen
key industries worldwide, works with companies of all
sizes around the world to deploy the full range of IBM
technologies. The fastest way to get more information
about IBM is through the IBM home page at
http://www.ibm.com
About superDimension
superDimension is an emerging leader in the minimally-invasive
diagnosis and treatment of lung disease via CT-guided
bronchoscopy. The superDimensionTM/Bronchus system answers
one of the most critical needs in the field, namely to
accurately reach lung locations that are far beyond the
bronchoscope’s own vision in a minimally-invasive manner.
Such locations are already where the majority of lung
procedures are aimed at and include peripheral lesions
as well as lymph nodes. For more information, visit
http://www.superdimension.com
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