Hansen Medical to Exhibit Magellan(TM) Robotic System at Vascular
InterVentional Advances Conference
MOUNTAIN VIEW, CA -- (Marketwired) -- 10/01/13 -- Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
announced that it will exhibit its Magellan(TM) Robotic System at the
Vascular InterVentional Advances (VIVA) conference, from October 8-11
at the Wynn Hotel in Las Vegas. The Company will be conducting
product demonstrations and exhibiting the Magellan Robotic System at
"We are excited for the opportunity to further showcase our
technology at this important annual meeting of leading clinicians
focused on the peripheral vasculature," said Bruce Barclay, President
and CEO of Hansen Medical. "Based on the feedback from many
successful cases at leading centers across the U.S. and Europe, the
precision and control offered by the Magellan Robotic System are
helping to bring predictability to a broad variety of endovascular
procedures, including endovascular aneurysm repair (EVAR), carotid
stenting, peripheral embolization, and chronic total occlusions. In
addition, the Magellan System has the potential to allow hospitals
and health systems to improve the efficiency and utilization of their
most profitable assets -- their operating rooms and cath labs -- by
reducing procedure times and streamlining endovascular procedures.
With several new robotic catheters in development, we believe the
Magellan Robotic System has an important role to play in driving the
continued evolution of endovascular treatment options for patients
with peripheral vascular disease."
About the Magellan(TM) Robotic System
Hansen Medical's Magellan
Robotic System is intended to be used to facilitate navigation to
anatomical targets in the peripheral vasculature and subsequently
provide a conduit for manual placement of therapeutic devices.
Magellan is designed to deliver predictability to simple and complex
endovascular procedures. Since its commercial introduction in the US
and Europe, the Magellan System has demonstrated its clinical
versatility in many cases in a broad variety of peripheral vascular
procedure types in centers across the US and Europe. The system is
based upon the flexible robotic technology incorporated in the
otic Catheter System currently sold in the U.S. and
Europe, which has been used in more than 10,000 patients, but
includes a number of key enhancements. In particular, the Magellan
-- Provides solid catheter stability for placement of therapeutic
-- Is designed to enable predictable procedure times and increased case
-- Allows for independent, individual robotic control of the distal tips
of both the outer sheath and the inner leader catheter, as well as
robotic manipulation of standard guidewires.
-- Is designed to allow for sufficient extension inside the body to
access hard to reach peripheral anatomy.
-- Preserves the open architecture featured in the Sensei System to allow
for the subsequent use of many 6F therapeutic devices on the market
-- Is designed to potentially reduce physician radiation exposure and
fatigue by employing a remote physician workstation.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a global
leader in intravascular robotics, developing products and technology
designed to enable the accurate positioning, manipulation and control
of catheters and catheter-based technologies. The Company's
Magellan(TM) Robotic System, 9Fr Magellan(TM) 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 both CE marking and 510(k) clearance and are commercially
available in the European Union, and the U.S. In the European Union,
the Company's Sensei(R) X Robotic Catheter System and Artisan(R) and
Artisan Extend(R) Control Catheters are cleared for use during
electrophysiology (EP) procedures, such as guiding catheters in the
treatment of atrial fibrillation (AF), and the Lynx(R) Robotic
Ablation Catheter is cleared for the treatment of AF. This robotic
catheter system is compatible with fluoroscopy, ultrasound, 3D
surface map and patient electrocardiogram data. In the U.S., the
Company's Sensei X Robotic Catheter System and Artisan and Artisan
Extend Control Catheters are cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in EP procedures. In the U.S., the Sensei X Robotic
Catheter 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 X
Robotic Catheter System and Artisan and Artisan Extend Control
Catheter for use with cardiac ablation catheters in the treatment of
cardiac arrhythmias, including AF, have not been established.
Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements regarding,
among other things, statements relating to goals, plans, 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 potential benefits of
our technology and the value of our intellectual property portfolio.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others: engineering, regulatory, manufacturing, sales
and customer service challenges in developing new products and
entering new markets; potential safety and regulatory issues that
could slow or suspend our sales; the effect of credit, financial and
economic conditions on capital spending by our potential customers;
the uncertain timelines for the sales cycle for newly introduced
products; 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; our ability to manage
expenses and cash flow, and obtain additional financing; and other
risks more fully described in the "Risk Factors" section of our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2013
filed with the SEC on August 9, 2013 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,
ven if new information becomes available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart
Design), Sensei and Lynx are registered trademarks, and Magellan and
NorthStar are trademarks of Hansen Medical, Inc. in the United States
and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
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