The Heart and Vascular Center Bad Bevensen Treats First Patients in Germany
With Hansen Medical's Magellan(TM) Robotic System
MOUNTAIN VIEW, CA -- (Marketwired) -- 04/03/13 -- Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
announced that the Heart and Vascular Center Bad Bevensen has
performed the first successful cases with the Magellan(TM) Robotic
System in Germany. These cases were performed by Dr. Thomas Nolte,
Director Vascular Center, and Chief of Vascular Surgery and the Wound
Center at the hospital.
"We are excited to announce the successful completion of the first
peripheral vascular procedures in Germany with the Magellan System by
Dr. Nolte at the Heart and Vascular Center Bad Bevensen," said Bruce
Barclay, president and CEO of Hansen Medical. "We continue to be very
encouraged by the breadth of clinical anatomy in which the Magellan
System is currently being used to treat patients with peripheral
vascular disease, and are pleased to have another site realizing the
real-world benefits of the Magellan System."
"We recently began using the Magellan System at the Heart and
Vascular Center Bad Bevensen and have experienced excellent results
thus far," commented Dr. Nolte. "Robotic supported navigation could
revolutionize the practice of interventional vascular medicine. The
Magellan System has the potential to deliver successful patient
outcomes in even complex procedures, while allowing for fast and
predictable cases and reducing the radiation burden for the surgeon."
"Our hospital has a history of evaluating new technology," said
Professor Gerhard Wimmer-Greinecker, MD, Medical Director of the
hospital. "We will continue to expand the use of the Magellan System
throughout the peripheral vasculature and are excited that we can now
offer patients throughout Germany these new minimally-invasive and
About the Magellan(TM) Robotic System
Hansen Medical's Magellan
Robotic System is based upon the flexible robotic technology
incorporated in the Sensei-X(R) Robotic Catheter System currently
sold in the U.S. and Europe, which has been used in over 10,000
patients, but includes a number of key enhancements. In particular,
the Magellan Robotic System:
-- Provides solid cathet
er 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 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(TM) Robotic System, Magellan
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 Control Catheter 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 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.
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 Magellan Robotic System for
hospitals, patients and physicians, expectations of shipments and
installations of our robotic systems, catheter sales, and procedures,
expectations of gross margins and operating expenses for 2013, the
sufficiency of the company's cash resources for supporting the
Company's operations, expected efficiencies from cost saving
initiatives, and the anticipated timing of commercially launching a
6F vascular catheter. 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 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 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 obligati
on 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.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
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