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
Magellan™ Robotic System at the 34th Annual Charing Cross
International Symposium from April 14-17 in London.
Hansen Medical will also be exhibiting its NorthStar™ Robotic
Catheter, designed to work with the Magellan Robotic System. The
NorthStar Catheter is designed to simplify and enhance catheter
navigation and therapeutic intervention through a variety of
clinical cases in the peripheral vasculature. The Magellan Robotic
System and NorthStar Robotic Catheter are CE marked and available
for sale in Europe.
The Company will be conducting product demonstrations and
exhibiting the Magellan Robotic System and NorthStar Robotic
Catheter at Booth 409.
"We are excited to showcase our Magellan Robotic System and
NorthStar Robotic Catheter at Charing Cross, a key conference of
vascular surgeons, as we believe these exciting new products have
the potential to enhance the way physicians navigate the
vasculature based on the initial clinical and pre-clinical work and
feedback from a number of leading clinicians worldwide," said Bruce
Barclay, president and CEO of Hansen Medical. "The system and
catheter give physicians maximum flexibility and control through
independent distal tip control of a catheter and a sheath as well
as through robotic manipulation of a standard guidewire from a
centralized, remote workstation. Moreover, this proprietary
technology is designed to deliver predictable catheter navigation
of peripheral vessels."
In addition, the Company will be sponsoring a Lunch Symposium
hosted jointly with Philips Healthcare, from 1:10pm-2:10pm on
Sunday, April 15, in the Blue Learning Center. During this
Symposium, Professor Jean-Paul de Vries, M.D., PhD., of St.
Antonius Hospital in Nieuwegein, The Netherlands, Professor
Jean-Pierre Becquemin, M.D., of Henri Mondor Hospital in Creteil,
France, Dr. Jean Bismuth, M.D., of the DeBakey Heart & Vascular
Center, Methodist Hospital in Houston, and Professor Nick Cheshire,
M.D., of St. Mary's Hospital, part of the Imperial College
Healthcare NHS Trust, in London, UK, will present on new frontiers
in hybrid operating rooms, advanced imaging, and endovascular
robotics.
"We are very pleased to host a Symposium with our partner
Philips. This Symposium reflects our strong relationship with a
global leader in medical imaging, and emphasizes the potential of
combining advanced imaging with our flexible robotic catheter
platform to deliver state-of-the-art solutions to our customers,"
concluded Barclay.
In addition, Dr. Celia Riga, M.D., of St. Mary's Hospital, part
of the Imperial College Healthcare NHS Trust, in London, will give
a presentation on Hansen Medical's flexible robotic catheters in
the CX Innovation Showcase session, at 12:05pm on Monday, April
16.
The Magellan Robotic System and NorthStar Robotic Catheter are
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.
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 over 7,000 patients with cardiac arrhythmia, but includes a
number of key enhancements. In particular, the Magellan Robotic
System:
- 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 with most 6F therapeutic devices on
the market today.
- Employs a catheter that is expected to be available in multiple
lengths and has a low profile with significant flexibility to be
compatible with most 6F treatment catheters currently used
today.
In 2010, the Company announced the completion of its
First-in-Man study in Europe during which 20 endovascular
procedures were successfully performed with an earlier version of
the Magellan Robotic System, demonstrating its potential to allow
physicians to effectively treat peripheral vascular disease, while
lessening radiation exposure.
In Europe, the Magellan Robotic System, including the NorthStar
Robotic Catheter and related accessories, are CE marked. In the
U.S., the Magellan Robotic System requires U.S. Food & Drug
Administration (FDA) clearance, and a 510(k) application is
currently pending. As such, the products are not commercially
available in the U.S.
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
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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