Pre-Clinical Study and Initial Clinical Experience Highlight Potential Benefits
of Hansen Medical's Robotic Technology in Treating
Study Results Published in Journal of Cardiovascular Surgery
MOUNTAIN VIEW, CA -- (Marketwired) -- 04/30/13 -- Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
announced the results from a recently published pre-clinical study
describing potential benefits of Hansen Medical's robotic technology
for the treatment of carotid arteries. The study results appeared in
the Journal of Cardiovascular Surgery, December 2012.
The study was conducted by a team of clinicians under the guidance of
Professor Nick Cheshire, MD of St Mary's Hospital and Head of
Circulation Sciences at Imperial College Healthcare. The purpose of
the study was to investigate whether the use of the robotic system
could reduce the embolic risk associated with carotid artery
stenting. The study was performed using a predecessor robot to Hansen
Medical's Magellan(TM) Robotic System in a pulsatile in vitro model
of the aortic arch and carotid arteries.
"A common concern of endovascular intervention in the aortic arch and
carotids is the risk of embolization and resulting neurologic
deficit, including stroke, due to the presence of vessel tortuosity,
angulation, arterial plaque and calcification, and poor patient
selection," said Professor Cheshire. "A high level of operator skill
and experience is important in reducing the risk of embolization, and
ensuring a successful outcome. However, few operators today possess
the skill necessary to consistently generate positive clinical
results in these complex cases."
"Our studies have demonstrated several potential benefits of using
Hansen's robotic catheter technology for complex endovascular
procedures, especially those procedures involving the aortic arch and
the great vessels including the carotid arteries," said Dr. Celia
Riga, MD Vascular Surgeon and NIHR Clinical Lecturer, Imperial
College London. "The preclinical data suggests that endovascular
robotic technology may facilitate endovascular intervention through
improved catheter maneuverability, stability and control, even for
less experienced interventionalists. This technology also has the
reduce manual skill required in the presence of
challenging anatomy and may thereby shorten the learning curve we
have historically seen in carotid artery stenting. Additional
potential benefits may include reduced procedure times through
efficient cannulation and lesion crossing, reduced instrumentation
and vessel wall contact, and overall stability for the controlled
delivery of therapeutic devices."
Beyond this pre-clinical study, the Company reported that other
centers have reported using the Magellan System to successfully
access and treat carotid arteries in patients. One of these centers
is the Baptist Cardiac & Vascular Institute (Baptist Hospital of
Miami), with the cases being performed by or under the direction of
Dr. Barry Katzen, founder and Medical Director of the Institute.
"Carotid artery intervention is one of the most challenging
endovascular procedures being performed today, given the anatomic
complexity and high clinical risk," said Dr. Katzen. "At the Baptist
Cardiac & Vascular Institute, we have successfully performed several
carotid procedures with the Magellan System. The ability to navigate
tortuous vessels and place a sheath in the carotid artery without
catheter changes, and with minimal vessel wall touches, offers great
"We are encouraged by the breadth of clinical anatomy in which the
Magellan System is currently being used to treat patients with
peripheral vascular disease," said Bruce Barclay, president and CEO
of Hansen Medical. "We believe that, as clinical experience with the
Magellan System grows, it will demonstrate that our technology
provides benefits within a broad variety of endovascular procedures
and for even the most skilled manual operators."
About Carotid Artery Disease
Carotid artery disease is a condition
in which the carotid arteries become narrowed or blocked, and the
resulting condition is called carotid stenosis. A common cause of
stroke is a blockage in the carotid arteries. Stroke, or
cerebrovascular accident, is most frequently caused by a sudden
stoppage of blood flow to a portion of the brain. Every year in the
United States an estimated 750,000 people become victims of stroke.
The carotid arteries carry blood to the brain; like the blood vessels
that supply blood to the heart, these arteries can become narrowed or
blocked. The blockages are deposits of cholesterol, or
atherosclerosis, that narrow the blood flow channel in the carotid
arteries. If these cholesterol deposits or blockages break or
rupture, small blood clots and cholesterol fragments break off from
the plaque, enter the blood flow to the brain, and can get caught in
a smaller blood vessel in the brain, thus stopping blood flow to that
area of the brain. The larger the cholesterol plaque and more severe
the blockage of the carotid artery, the higher the risk of stroke.
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 catheter 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
d 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 the Magellan(TM) Robotic System in
treating disease in the carotid arteries and other parts of the
peripheral vasculature. Important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements include, among others: adverse events or
unfavorable clinical results, including patient injury or death;
insufficient or unfavorable clinical data; potential safety and
regulatory issues that could slow or suspend our sales; the effect of
credit, financial and 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 Quarterly 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
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart
Design), Sensei and Lynx are registered trademarks, and Magellan is a
trademark of Hansen Medical, Inc. in the United States and other
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
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