U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of Hansen Medical Sensei(R) X Robotic Catheter Syst
02 11월 2010 - 5:01AM
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 it has received
unconditional Investigational Device Exemption (IDE) approval from
the U.S. Food & Drug Administration (FDA) authorizing a
clinical trial to investigate the use of the Sensei® X Robotic
Catheter System and the Artisan™ Control Catheter for treatment of
Atrial Fibrillation (AF), the most common cardiac arrhythmia. The
trial was conditionally approved earlier this year as announced in
a Hansen Medical press release on May 12, 2010.
"This comparative study is an important milestone toward our
goal of expanding the universe of patients that benefit from robot
assisted AF procedures," said Hansen Medical President and CEO
Bruce Barclay. "We are encouraged and gratified by the prestigious
medical centers and physicians that are or have expressed interest
in participating in the trial, and we believe that the study
results will provide an important comparative assessment of the use
of robotic technology for this application."
Conditional approval for the trial was granted by the FDA in
May, and under that approval, the first cases in the ARTISAN AF
Trial have been completed by site principal investigator Joseph
Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac
Arrhythmia Institute (TCAI) at St. David's Medical Center and his
team. The principal investigator of the full trial is Andrea
Natale, M.D., F.A.C.C., F.H.R.S., executive director for TCAI.
Designed to enroll up to 300 patients at 14 leading hospitals,
the ARTISAN AF Trial is a prospective, randomized study of the
Hansen Medical Sensei X System for introducing and positioning the
Biosense Webster NAVISTAR® THERMOCOOL® Catheter in patients with
AF. The trial will enroll patients with symptomatic,
drug-refractory paroxysmal AF at a 2:1 ratio and evaluate robotic
technique versus manual technique for the ablation of AF. The study
will track two primary endpoints: Safety, defined as the absence of
early onset of all major adverse events, and efficacy, defined as
freedom from AF through one year. The trial protocol recommends
that the IntelliSense® force sensing system be used to guide
ablative lesion placement. The IntelliSense readings of 10-20g
during ablation, with a maximum of 40g are recommended. The
protocol also recommends that ablation is performed using irrigated
radio frequency (RF) power settings of 20-25W with a maximum power
of 30W, and a maximum temperature of 50 degrees Celsius.
Additionally, data will be collected to compare the reduction in
radiation exposure and the potential improvements in
single-procedure success rates.
Atrial Fibrillation is the most common cardiac arrhythmia, and
it affects an estimated 3.3 million Americans and 4.5 million
Europeans. This number is expected to increase due to an aging
population and a rising number of people with chronic heart
disease. AF is associated with increased long-term risk for severe
and disabling stroke.
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. The flexible
robotic platform 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.
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.
Examples of such statements include statements about the potential
effects of our vascular robotic system on the vascular procedures
and the timing of commercializing our vascular robotic system.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others, potential safety and regulatory issues that
could delay, suspend or terminate future clinical studies or
regulatory approvals, challenges in designing, engineering and
manufacturing systems to function as intended, uncertain timelines,
costs and results of clinical trials, and the scope and validity of
intellectual property rights applicable to products being
developed. 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 August 6, 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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