Hansen Medical to Highlight New Lynx(TM) Robotic Ablation Catheter, Other New Products at the Boston Atrial Fibrillation Symposi
07 1월 2011 - 6:01AM
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 its
new Lynx™ Robotic Ablation Catheter and other innovative new
products at the 16th Annual Boston Atrial Fibrillation Symposium
from January 13-15 at the Seaport Hotel and World Trade Center in
Boston. The Company will be exhibiting all of its new and
commercially available products at Booth #304.
The Lynx Robotic Ablation Catheter is a small profile, flexible
irrigated ablation catheter that offers stability and accuracy
during the treatment of atrial fibrillation (AF) and other
electrophysiology disorders. The catheter obtained CE Mark approval
in July, 2010 and, following a limited release in late 2010, will
be fully released commercially throughout Europe this month. The
catheter is not approved for use in the United States.
"The Lynx Robotic Ablation Catheter includes a proprietary
irrigated RF ablation tip, demonstrating Hansen Medical's strategy
to expand its target market beyond its core robotic navigation
technology," said Bruce J Barclay, President and CEO of Hansen
Medical. "The early clinical results of our limited release of the
Lynx Ablation Catheter last quarter have been positive, making the
success of the Lynx Ablation Catheter in Europe, and eventually the
U.S., an important part of our plan to develop and market
proprietary products that provide us greater potential for
increasing market share and higher margins. We are looking forward
to exhibiting this new catheter and its benefits to a broad segment
of European electrophysiologists at this important Symposium."
The Lynx Robotic Ablation Catheter is a smaller profile, more
flexible all-in-one catheter and therapy system that provides many
of the benefits of the Artisan™ robotic catheter while allowing for
improved flexibility and ease-of-use benefits over other solutions
for treating AF. Professor Richard Schilling, M.B., B.S., F.R.C.P.,
M.D., Consultant Cardiologist at London Bridge Hospital (UK), said,
"The Lynx irrigated ablation catheter is an ideal catheter for the
treatment of paroxysmal AF as it appears to have greater
flexibility and range of movement than other commercially available
ablation catheters."
Other highlights of the Symposium include:
- A presentation by Luigi DiBiasi, M.D., based on the results of
his clinical experience with the Lynx Robotic Ablation Catheter in
a poster abstract titled, "Preliminary acute results of Robotic
Catheter Ablation of Atrial Fibrillation utilizing the Lynx Robotic
Catheter System in humans: safety and feasibility."
- Hands on demonstrations for physicians of the Company's Artisan
Extend™ Control Catheter, which works with Hansen Medical's
proprietary Sensei® X Robotic Catheter System and provides advanced
navigational capabilities compared to the original Artisan
catheter. This advanced system allows physicians to reach more
difficult-to-access parts of the anatomy while retaining the
stability needed for delicate cardiac arrhythmia procedures.
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® system and its Sensei X Robotic
Catheter System 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. The U.S.
product labeling therefore provides that the safety and
effectiveness of the Sensei and Sensei X systems for use with
cardiac ablation catheters in the treatment of cardiac arrhythmias,
including atrial fibrillation (AF), have not been established
during EP procedures, such as guiding catheters in the treatment of
AF. In the European Union, the Sensei and the Sensei X systems are
cleared for use during EP procedures, such as guiding catheters in
the treatment of AF. Additional information can be found at
www.hansenmedical.com.
Forward-Looking Statements This press
release contains forward-looking statements that involve risks,
uncertainties, assumptions and other factors which, if they do not
materialize or prove correct, could cause Hansen's results to
differ materially from those expressed or implied by such
forward-looking statements. All statements, other than statements
of historical fact, are statements that could be deemed
forward-looking statements, including statements containing the
words "potential," "plan" and similar words. Hansen Medical intends
such forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Exchange Act and the Private Securities Litigation Reform
Act of 1995. Examples of such statements include statements about
the potential for increasing market share and higher margins based
on the early results of the Lynx Robotic Ablation Catheter, and the
expected timing and scope of the full commercial release of the
Lynx Ablation Catheter in Europe. Important factors that could
cause actual results to differ materially from those indicated by
forward-looking statements include, among others, potential safety
and regulatory issues that could delay, suspend or terminate
clinical studies, regulatory approvals or sales, challenges in
designing, engineering and manufacturing systems to function as
intended, uncertain timelines, costs and results of clinical trials
and development of new products, our ability to plan and manage
cost-reduction or operational efficiency initiatives, the scope and
validity of intellectual property rights applicable to products
being developed, and our ability to remediate material weaknesses
in internal controls over financial reporting. These and other
risks are described in greater detail under the heading "Risk
Factors" contained in our periodic SEC filings, including our
Quarterly Report on Form 10-Q filed with the SEC on November 9,
2010. 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, Hansen Medical & Heart Design,
and Sensei are registered trademarks, and Artisan and Lynx are
trademarks, of Hansen Medical, Inc. in the United States and other
countries.
Investor Contacts: Peter Osborne Interim CFO Hansen
Medical 650.404.5800 Matt Clawson Allen & Caron Inc
949.474.4300 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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