Hansen Medical Announces Enrollment of First Patients Into New Clinical Study Evaluating the Use of the Artisan(R) Family of ...
05 8월 2013 - 9:00PM
Marketwired
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, today announced that the first patients
have been successfully enrolled in the new study design of its
ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of
Hansen Medical's Artisan® family of Control Catheters with its
Sensei® X Robotic Catheter System for treatment of Atrial
Fibrillation (AF), the most common cardiac arrhythmia. In May, the
Company announced that it had received conditional approval of the
new study design from the U.S. Food and Drug Administration (FDA).
Under the revised protocol, the study will be a single arm,
target performance goal study enrolling as few as 125 subjects at
up to 14 investigational sites. The principal investigator of the
full trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive
director for Texas Cardiac Arrhythmia Institute. The co-principal
investigator is Joseph Gallinghouse, M.D., electrophysiologist, at
the Texas Cardiac Arrhythmia Research Foundation (TCARF) and his
team. Dr. Gallinghouse was the first physician to enroll a patient
into the study under the revised protocol following IRB
approval.
"I am pleased to be the first physician to enroll a patient into
this new study," said Dr. Gallinghouse. "The new study design
recently agreed upon with the FDA will greatly facilitate
enrollment in the trial, and allow us to evaluate clinical
endpoints in an expedited fashion. I look forward to continuing to
enroll patients into and completing this critical evaluation of
ablation of atrial fibrillation using robotic navigation."
"The enrollment of patients into this study is an important
milestone for Hansen Medical," said Hansen Medical President and
CEO, Bruce Barclay. "If successful, we intend to use the data
derived from this study to support a submission to the FDA to
obtain approval for a broader label claim for use of our Artisan
family of Control Catheters with our Sensei X Robotic Catheter
System in atrial fibrillation procedures. The achievement of a
broader label claim has the potential to drive further growth of
our U.S. EP business."
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 Sensei®
X Robotic Catheter System Through continued
advancement of medical robotics, Hansen Medical has developed a
next generation minimally-invasive, robotic catheter system, the
Sensei X Robotic Catheter System, which combines advanced levels of
3D catheter control and 3D visualization. This unique, state of the
art technology has been used in over 10,000 patients, and is
powered by an accurate, robotically controlled arm that allows for
catheter navigation, stability and positioning within the patient's
heart atria, allowing for the following system advantages:
- Catheter Stability with Force-Sensing
- Instinctive 3D Control
- Potential for Reduced Fluoro Time for Physician
About Hansen Medical, Inc. Hansen Medical,
Inc., based in Mountain View, California, is a 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™
Robotic System, 9Fr 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® X Robotic Catheter System and Artisan®
and Artisan Extend® Control Catheters are cleared for use during
electrophysiology (EP) procedures, such as guiding catheters in the
treatment of atrial fibrillation (AF), and the Lynx® 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 and Artisan
Extend Control Catheters are cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in EP procedures. In the U.S., the Sensei X Robotic
Catheter 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 Robotic Catheter System and Artisan and Artisan Extend
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.
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," "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
regarding the timing and potential results of the ARTISAN-AF Trial
and statements about the anticipated growth in Hansen Medical
intravascular robotics technology for EP and vascular applications.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others: factors relating to engineering, regulatory,
manufacturing, sales and customer service challenges in developing
new products and entering new markets; the commercial viability of
our products in the electrophysiology and 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 Quarterly
Report on Form 10-Q for the quarter ended March 31, 2013 filed with
the SEC on May 10, 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. The Company undertakes no obligation to revise or
update information herein to reflect events or circumstances in the
future, even if new information becomes available.
Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting,
Inc. Brian Ritchie 212.850.5683 Email Contact John Capodanno
212.850.5705 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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