Hansen Medical Showcases New Generation Robotic Catheter Technology at Boston Atrial Fibrillation Symposium
11 1월 2007 - 8:00PM
Business Wire
Hansen Medical, Inc., (Nasdaq:HNSN) will showcase its new
generation robotic technology for accurate and stable control of
catheter movement during cardiac procedures here at the 12th Annual
Boston Atrial Fibrillation (AF) Symposium, January 11-13, 2007. The
Sensei� Robotic Catheter System is designed to guide catheters for
mapping heart anatomy during the treatment of patients suffering
from abnormal heart rhythms, or arrhythmias. The company recently
announced the successful completion of a 20-patient prospective
trial and seven-day follow-up using the Sensei system to guide
catheters for mapping heart anatomy, which is a critical step in
identifying heart tissue that generates abnormal heart rhythms.
Data from the follow-up showed no device-related adverse events,
and is being prepared as part of a submission to the U.S. Food
& Drug Administration (FDA) in support of a 510(k) currently
under review. �The new robotic catheter system has the potential to
fundamentally change the way electrophysiology procedures are
performed worldwide and make it possible for a broader group of
physicians to perform complex cardiac procedures such as cardiac
arrhythmia mapping,� said Wyn Davies, M.D., FRCP, FHRS, consultant
cardiologist, St. Mary�s Hospital, London, and principal
investigator of the clinical trial. Currently, cardiac
electrophysiology procedures are performed using a manual technique
that requires physicians to perform a series of complex
manipulations at one end of the catheter with inadequate assurance
that the tip of the catheter will respond as desired while inside a
patient�s heart. As a result, achieving stable contact at every
anatomic site within the heart necessary for successful mapping can
be difficult. Insufficient contact between the catheter tip and the
inside of the heart wall can lead to highly variable and less than
optimal procedure outcomes. �There is a medical need for broader
use of catheter-based procedures for diseases where catheters are
rarely used today, and we believe our robotic platform will enable
more physicians to perform complex interventional procedures
through greater ease of use, and possibly improve patient
outcomes,� said Frederic Moll, M.D., founder and chief executive
officer of Hansen Medical. To date, 83 cardiac procedures have been
performed on patients in Europe using the Sensei Robotic Catheter
System. The new technology incorporates fluoroscopic, intracardiac
ultrasound, 3D surface map and patient electrocardiogram data into
one portable workstation. The workstation can be easily moved among
catheter lab suites and does not require costly construction of a
specialized room. Hansen Medical anticipates that its proprietary
system will enhance the ease-of-use and stability of catheter-based
procedures by offering physicians better control over catheter
placement, as well as potentially decrease procedure times and
radiation exposure. About Hansen Medical, Inc. Hansen Medical,
based in Mountain View, Calif., was founded in 2002 to develop
products and technology using robotics for the accurate
positioning, manipulation and stable control of catheters and
catheter-based technologies. The Sensei system is currently under
review for FDA clearance to guide catheters for mapping anatomy of
the heart. Additional information can be found at
www.hansenmedical.com. This press release contains forward-looking
statements that are subject to a number of risks and uncertainties,
including statements about our clinical development results and
whether the FDA will consider this sufficient and appropriate to
support our planned 510(k) clearance. Actual results may differ
materially from those set forth in this press release due to the
risks and uncertainties inherent in our business, including
potential safety issues; the scope of potential use of our
products; the scope and validity of intellectual rights applicable
to our products; competition from other companies; our ability to
obtain additional financing to support our operations; our ability
to successfully launch and market our product; and other risks
detailed in the �Risk Factors� section of our Registration
Statement on Form S-1. We undertake no obligation to revise or
update information herein to reflect events or circumstances in the
future, even if new information becomes available.
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