Hansen Medical to Highlight Sensei(R) X Robotic Catheter System and Software Enhancements at the Heart Rhythm Society Annual ...
04 5월 2012 - 5:01AM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible
robotics and the developer of robotic technology for accurate 3D
control of catheter movement, today announced it will showcase the
Sensei® X Robotic Catheter System at the Heart Rhythm Society's
33rd Annual Scientific Sessions from May 9-12, 2012 in Boston. The
Company will also be showcasing an upcoming software release for
the Sensei X Robotic Catheter System at Booth 465.
This upcoming software release will include an updated CoHesion™
Module which combines the accuracy of 3D catheter control with the
visual guidance of 3D electroanatomical mapping, a synergistic
technology combination that realizes the potential of instinctive
motion. It also will achieve compatibility and integration with St.
Jude Medical's EnSite Velocity 3.0 Cardiac Mapping System, recently
released by St. Jude Medical. In addition, the software will
include changes to the user interface which allows
electrophysiologists (EPs) to perform instinctive 3D catheter
control when using other 3D mapping systems without the CoHesion
Module, specifically Biosense Webster's CARTO™ Navigation
System.
"The majority of our customers are currently using either CARTO
or Ensite Velocity 3D mapping systems when performing EP
procedures, and in both cases, physicians will have control of both
the robotic catheter as well as the orientation of the 3D map at
the Sensei X physician workstation, allowing instinctive 3D
control," said Bruce Barclay, President and CEO of Hansen Medical.
"Gone are the days when the EP can only control the manual catheter
and has to call out instructions to a technologist at the 3D
mapping system to change the map orientation for him. We are
pleased with the technological advances we have made to enable 3D
catheter control with greater ease."
Other highlights of the Heart Rhythm Society's Scientific
Sessions include:
- Dr. Andrea Natale, executive director at the St. David's Texas
Cardiac Arrhythmia Institute in Austin, Texas will speak about the
Sensei X Robotic Catheter System in a presentation entitled
"Magnetic and Robotic Navigation Systems: Have Our Dreams Been
Realized?" at the Seaport World Trade Center on Wednesday, May 9,
2012, 8:00 AM - 9:35 AM
- Professor Michael Mangrum, M.D. will discuss his clinical
experience using the Sensei X Robotic Catheter System in a
presentation entitled "Remote and Robotic Technology: Does it
Work?" in Room 210A on Thursday, May 10, 2012, 11:00 AM -11:30
AM
About Sensei® X Robotic Catheter System
Through continued advancement of medical robotics, Hansen Medical
has developed a next generation minimally-invasive, robotic
catheter system, the Sensei X Robotic Catheter System which
combines advanced levels of 3D catheter control and 3D
visualization. This unique, state of the art technology is powered
by a highly accurate, robotically controlled arm that allows for
catheter navigation, stability and positioning within the patient's
heart, allowing for the following system advantages:
- Catheter Stability with Force-Sensing
- Instinctive 3D Control
- Reduced Fluoro Time for Physician
About Hansen Medical, Inc. Hansen Medical,
Inc., based in Mountain View, California, develops products and
technology using robotics for the accurate positioning,
manipulation and control of catheters and catheter-based
technologies. The Company's Sensei® X Robotic Catheter System and
Artisan Control Catheter were cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in electrophysiology (EP) procedures. This robotic
catheter system is compatible with fluoroscopy, ultrasound, 3D
surface map and patient electrocardiogram data. In the United
States, the Sensei System is not approved for use in guiding
ablation procedures; this use remains experimental and is currently
under investigation in a multi-center IDE study. The U.S. product
labeling provides that the safety and effectiveness of the Sensei X
System and Artisan Control Catheter for use with cardiac ablation
catheters in the treatment of cardiac arrhythmias, including atrial
fibrillation (AF), have not been established. In the European
Union, the Sensei X System and Artisan Control Catheter are cleared
for use during EP procedures, such as guiding catheters in the
treatment of AF, and the Lynx® Robotic Ablation Catheter is cleared
for the treatment of AF. The Company's Magellan™ Robotic System,
NorthStar™ Robotic Catheter and related accessories, which are
intended to facilitate navigation to anatomical targets in the
peripheral vasculature and subsequently provide a conduit for
manual placement of therapeutic devices, have undergone conformity
assessment and CE marking and are commercially available in the
European Union.
In the U.S., the Magellan™ Robotic System, the NorthStar™
Robotic Catheter and accessories are the subject of a current
filing with the FDA and are not commercially available. Additional
information can be found at www.hansenmedical.com.
Forward-Looking Statements This press
release contains forward-looking statements regarding, among other
things, statements relating to goals, plans, expectations,
objectives, milestones and future events. All statements, other
than statements of historical fact, are statements that could be
deemed forward-looking statements, including statements containing
the words "plan," "expects," "potential," "believes," goal,"
"estimate," "anticipates," and similar words. These statements are
based on the current estimates and assumptions of our management as
of the date of this press release and are subject to risks,
uncertainties, changes in circumstances and other factors that may
cause actual results to differ materially from the information
expressed or implied by forward-looking statements made in this
press release. Examples of such statements include statements about
the anticipated growth of Hansen's flexible robotic technology in
both EP and vascular applications and statements about the
anticipated timing of regulatory clearances, including 510(k)
clearance in the United States. Important factors that could cause
actual results to differ materially from those indicated by such
forward-looking statements include, among others: engineering,
regulatory and sales challenges in developing new products and
entering new markets; potential safety and regulatory issues that
could slow or suspend our sales; the uncertain timelines, costs and
results of pre-clinical and clinical trials; the rate of adoption
of our systems and the rate of use of our catheters; the scope and
validity of intellectual property rights applicable to our
products; competition from other companies; our ability to recruit
and retain key personnel; our ability to maintain our remedial
actions over previously reported material weaknesses in internal
controls over financial reporting; the effect of credit, financial
and economic conditions on capital spending by our potential
customers; our ability to manage expenses and obtain additional
financing; and other risks more fully described in the "Risk
Factors" section of our Annual Report on Form 10-K for the year
ended December 31, 2011 filed with the SEC on March 15, 2012 and
the risks discussed in our other reports filed with the SEC. Given
these uncertainties, you should not place undue reliance on the
forward-looking statements in this press release. We undertake no
obligation to revise or update information herein to reflect events
or circumstances in the future, even if new information becomes
available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart
Design), and Sensei are registered trademarks of Hansen Medical,
Inc. in the United States and other countries.
Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting,
Inc. Sharrifah Al-Salem, CFA 415.293.4414 Email Contact John
Capodanno 212.850.5705 Email Contact
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