Pre-Clinical In-Vivo Study Highlights Potential for Reduction in Vessel Trauma and Improvements in Efficiency With Hansen Medica
22 6월 2010 - 10:48PM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN) announced the successful
completion of a pre-clinical in-vivo study evaluating its new
vascular robot, which demonstrated improvements in catheter
navigation, reductions in vessel trauma during catheter
manipulation, and improvements in access time for some vessels, as
compared to manual catheter manipulation during endovascular
procedures. Results also showed that the company's vascular robot
has the potential to standardize catheter navigation, which may
lead to more predictable procedures. The early, but encouraging
results were presented June 12, 2010 at the Society of Vascular
Surgery's 2010 Vascular Annual Meeting in Boston.
The pre-clinical in-vivo study was performed under the guidance
of Alan Lumsden, M.D. and Jean Bismuth, M.D., from the DeBakey
Heart & Vascular Center at Methodist Hospital in Houston. The
study endpoint was safe cannulation (insertion of a catheter into a
branch vessel) and deployment of balloon and stent in the
contralateral superficial femoral artery, the renal artery, and the
mesenteric arteries. Safety was evaluated through both gross visual
examination and histopathology of target vessels, and angiographic
evidence of trauma.
"Our in-vivo experience using Hansen Medical's new vascular
platform demonstrated that robotic catheterization has the
potential to be less traumatic to vascular anatomy when compared to
manual catheterization," said Dr. Bismuth, assistant professor,
Methodist Hospital, Houston. "This is based on recent work we
performed showing reductions in vessel trauma observed on
histological evaluation of arteries accessed robotically in
comparison to those accessed manually. In addition, these results
demonstrate that the use of this vascular robot may reduce harmful
radiation exposure to both the patient and clinician."
The pre-clinical study featured the use of a new, smaller
vascular robotic catheter, which incorporates a removable,
robotically shapeable diagnostic catheter inside of a 6 French (1
French = 1/3 mm) robotically shapeable sheath for delivery of
therapeutic devices. Specifically, a single vascular catheter was
able to successfully navigate the aorta and access several primary
and secondary branches. Additionally, three stents were
successfully delivered through the 6 French robotic sheath in
several target vessels.
According to Dr. Bismuth, "The smaller size of the catheter
lends itself to a large number of vascular applications, and the
new Hansen Medical vascular robot has the potential to improve the
learning curve for operators."
"We are extremely encouraged by the results of this pre-clinical
in-vivo study, as this accomplishment brings us one step closer to
the introduction of a new Hansen Medical robot and catheters for
use in the vascular system," said Robert Mittendorff, M.D., vice
president of marketing and business development. "We believe our
new robot and its clinical capabilities for complex vascular
procedures will open up significant, new opportunities for Hansen
Medical in the near future."
Hansen Medical's flexible robotic technology provides physicians
with the ability to precisely manipulate catheters using advanced
three-dimensional controls and visualization. Hansen Medical
continues to develop and advance flexible robotics technology for
applications including vascular and interventional medicine. The
Hansen Medical vascular robot has not received regulatory clearance
and is currently not available for sale.
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 robotic navigation
system enables clinicians to place mapping catheters in
hard-to-reach anatomical locations within the heart easily,
accurately and with stability during complex cardiac arrhythmia
procedures. Hansen Medical's Sensei® system and its Sensei X
Robotic Catheter System are compatible with fluoroscopy,
ultrasound, 3D surface map and patient electrocardiogram data. The
remote navigation platform was cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in Electrophysiology (EP) procedures. 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. 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. 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.
Hansen Medical, Heart Design, Hansen Medical & Heart Design,
Sensei and IntelliSense, are registered trademarks, and Artisan and
Instinctive Motion are trademarks of Hansen Medical, Inc. in the
United States and other countries.
News Media Contact: Amy Cook 925.552.7893 Email Contact
Investor Contacts: Peter Osborne 650.404.5800 Email Contact
Lasse Glassen Financial Relations Board 213.486.6546 Email
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