News
(http://www.hansenmedical.com)
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular
robotics and the developer of robotic technology for accurate 3D
control of catheter movement, today announced it will exhibit its
Magellan? Robotic System at the 2012 Vascular Annual Meeting@ of the
Society for Vascular Surgery@ from June 7-9 at Gaylord National Resort
& Convention Center in National Harbor, MD. The Company recently
announced receipt of 510(k) clearance from the U.S. Food and Drug
Administration for the Magellan Robotic System, including the catheter
and accessories, and will commence initial launch activities in the
U.S. immediately.
The Magellan Robotic System 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 results in a new standard for peripheral vascular intervention
with the potential to deliver revolutionary lesion access, precise
distal tip control, solid catheter stability and consistent procedural
efficiency.
"We are excited to showcase our Magellan Robotic System at this
important annual meeting of leading vascular surgeons, as we believe
this product has the potential to enhance the way physicians navigate
the vasculature based on the clinical and pre-clinical work completed
to date and feedback from a number of leading clinicians worldwide,"
said Bruce Barclay, President and CEO of Hansen Medical. "The robotic
system and robotic 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."
The Company will be exhibiting the Magellan Robotic System and
conducting product demonstrations at Booth 418.
In addition, Jean Bismuth, M.D., of the DeBakey Heart & Vascular
Center, Methodist Hospital in Houston, will be present at Hansen
Medical's booth at 2:00 p.m. on Thursday, June 7th, to conduct product
demonstrations and to share his experience using the Magellan Robotic
System with other physicians in attendance.
"We are very pleased to have Dr. Bismuth, one of the pioneering
clinicians in the use of intravascular robotics in endovascular
procedures, spend time at our booth to conduct demonstrations of our
Magellan Robotic System and to share his preclinical experience using
our robotic catheter technology," Barclay added.
About the Magellan? Robotic SystemHansen 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 8,000 patients, but includes
a number of key enhancements. In particular, the Magellan Robotic
System:
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. 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 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 both CE marking and 510(k) clearance and are commercially
available in the European Union, and the U.S.
Additional information can be found at
www.hansenmedical.com(http://ctt.marketwire.com/?release=896103&id=1687240&type=1&url=http%3a%...).
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," 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 on the vascular procedures and the timing
and results of commercializing our Magellan Robotic System. 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2012 filed with
the SEC on May 7, 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, and Magellan is a
trademark of Hansen Medical, Inc. in the United States and other
countries.


