Hansen
Medical announces enrollment of first patients into new clinical study
evaluating the use of the Artisan(R) family of Control Catheters with the Sensei(R)
X Robotic System for the treatment of atrial fibrillation. If successful, Hansen Medical intends
to use the new clinical study data to support a submission to the FDA to obtain
approval for a broader label claim for use of the Artisan family of Control Catheters
with the Sensei X Robotic Catheter System in atrial fibrillation procedures.
Full press release below.
SOURCE: Hansen Medical, Inc.
MOUNTAIN VIEW, CA -- (Marketwired) -- 08/05/13 -- Hansen
Medical, Inc. (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 (SCUR) 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
Source:
Hansen Medical, Inc.
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