Hansen Medical's Investigational Flexible Catheter Vascular Robotic System to Be Presented at International Symposium
11 11월 2010 - 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 that its
investigational flexible catheter vascular robotic system,
including an overview of its preclinical evaluation and the
recently completed First in Man study, will be presented at the
upcoming 37th annual VEITHsymposium™ November 17-21 at the Hilton
New York in New York City.
"This five-day annual symposium is one of the year's most
important gatherings of vascular surgeons and interventionalists
from around the world. Based on the initial clinical work, I
believe our robotic system has the potential to standardize
catheter navigation," said Bruce Barclay, president and CEO of
Hansen Medical. "The expected regulatory submission, clearance and
commercialization of our vascular robotic technology next year is a
critical element to our overall business strategy, and this
conference allows the progress made to be shared with many of the
world's foremost clinicians and thought leaders in the vascular
surgery and interventional community."
The presenters will include the clinicians that conducted the
First in Man Study, including Alan Lumsden, M.D., and Jean Bismuth,
M.D., of the DeBakey Heart & Vascular Center in Houston, Texas;
and Borut Gersak, M.D., Ph.D., and Milenko Stankovic, M.D., of the
University Medical Centre, Ljubljana, Slovenia. Professor Gersak
and Professor Lumsden were the study's principal investigators. The
presenters will also include Nick Cheshire, M.D., and Celia Riga,
MB BS, BSc, MRCS (Eng), of St. Mary's Hospital, part of the
Imperial College Healthcare NHS Trust, in London, England, who have
been pioneering the use of flexible robotics in vascular
interventions.
Along with the presentations at the VEITHsymposium, an
additional presentation featuring Hansen Medical's investigational
vascular robotic system will be offered at the AIMsymposium™, which
is focused on interventionalists, sponsored by the Cleveland Clinic
and being held concurrently at the Hilton New York.
The presentations will include:
- A breakfast session co-chaired by Professor Alan Lumsden, and
Professor Nick Cheshire, from 6:30 a.m.-8:30 a.m. on Saturday,
November 20. The session is intended for endovascular specialists
interested in participating in potential post-market studies using
Hansen Medical's investigational vascular robotic system, and will
feature a series of presentations covering the vascular clinical
and preclinical work performed on the Company's robotic Sensei® X
system and investigational vascular platform. Presenters include
Dr. Jean Bismuth, Dr. Celia Riga, Professor Borut Gersak, and Dr.
Milenko Stankovic.
- Professor Nick Cheshire will present "Robotics and Endovascular
Navigation: Progress in and Importance for In Situ Fenestration and
other Complex Procedures," from 11:32 a.m.-11:37 a.m. on Saturday,
November 20.
- At the AIMsymposium, Professor Alan Lumsden will present a
review of the investigational vascular robotic system and
highlights of the First in Man Study at noon, Thursday, November
18.
The Hansen Medical vascular robotic system requires regulatory
clearance and is not commercially available.
The vascular market is large and rapidly growing, driven in
large part by an aging population, the prevalence of diabetes and
obesity, and an increase in disease awareness. Of the more than 2
million vascular procedures done each year, approximately one-third
to one-half of them are potentially addressable by Hansen Medical's
technology.
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 "plan," "expects," "believes," "goal," "estimate," 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 expected
timing of regulatory submission, approval, clearance, and
commercialization of our vascular robotic system, expectations
regarding effects on clinical procedures, and expectations
regarding clinical and operating actions. 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 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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