Hansen Medical's Magellan(TM) Robotic System Scheduled to Be Utilized in Five Live Cases at EuroPCR 2013
08 5월 2013 - 5:01AM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today announced that its Magellan™ Robotic
System is scheduled to be utilized in several live cases to be
broadcast at EuroPCR 2013, which takes place May 21 - May 24 in
Paris, France. Professor Jean-Pierre Becquemin, Professor Hicham
Kobeiter, Professor P. Desgranges, and Dr. Frédéric Cochennec are
scheduled to use the Magellan System in five complex endovascular
cases.
"We are very pleased to have our Magellan System scheduled to be
featured in several live cases at this important interventional
medicine meeting," said Bruce Barclay, President and CEO of Hansen
Medical. "Live cases such as these are critical validations of our
technology from key opinion leaders in cardiac and peripheral
vascular interventions."
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the
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™ 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 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® X Robotic
Catheter System and Artisan Control Catheter are cleared for use
during electrophysiology (EP) procedures, such as guiding catheters
in the treatment of atrial fibrillation (AF), and the Lynx® 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 Control
Catheter were cleared by the U.S. Food and Drug Administration for
manipulation and control of certain mapping catheters in EP
procedures. 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 X System and Artisan 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.
About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is based upon the
flexible robotic technology incorporated in the Sensei-X® Robotic
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 Robotic System:
- Provides solid catheter stability for placement of therapeutic
devices.
- Is designed to enable predictable procedure times and increased
case throughput.
- 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 today.
- Is designed to potentially reduce physician radiation exposure
and fatigue by employing a remote physician workstation.
Forward-Looking Statements
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," "outlook," 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 Magellan Robotic
System for hospitals, patients and physicians, and statements about
the potential benefits to the Company of live broadcast of cases
utilizing our Magellan system. 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; the commercial
viability of our products in the vascular markets; potential safety
and regulatory issues that could slow or suspend our sales; the
effect of economic conditions on capital spending by our potential
customers; the rate of adoption of our systems and the rate of use
of our systems by hospitals and physicians; the risk of adverse
events or clinically insignificant outcomes of procedures
(including live cases) using our system; the risk that one or more
scheduled live cases may be cancelled; 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, 2012 filed with the SEC
on March 18, 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, even 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.
Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting,
Inc. Brian Ritchie 212.850.5683 Email Contact John Capodanno
212.850.5705 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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