Hansen Medical Announces U.S. Food and Drug Administration Conditionally
Approves New Study Design Evaluating the Use of the
Artisan(R) Family of Control Catheters With the Sensei(R) X Robotic
System for the Treatment of Atrial Fibrillation
Company Seeks to Expand U.S. Labeling; Anticipates Faster Enrollment
Under Revised Protocol
MOUNTAIN VIEW, CA -- (Marketwired) -- 05/29/13 -- Hansen Medical,
Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today
announced that it has received conditional approval from the U.S.
Food and Drug Administration (FDA) to change the study design of its
ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of
Hansen Medical's Artisan(R) family of Control Catheters with its
Sensei(R) X Robotic Catheter System for treatment of Atrial
Fibrillation (AF), the most common cardiac arrhythmia.
Under the revised protocol, the study will be a single arm, target
performance goal study enrolling as few as 100 subjects at up to 14
investigational sites. The study will track two primary endpoints:
Safety, defined as the incidence of early onset major adverse events
and major complications through six months, and efficacy, defined as
freedom from AF through one year. Additionally, data will be
collected to measure radiation exposure and single-procedure success
rates. The study will evaluate the use of the Sensei X System with
the family of Artisan(R) Control Catheters for introducing and
positioning the Biosense Webster NAVISTAR(R) THERMOCOOL(R) Catheter
in patients with paroxysmal AF. While the approval of the revised
protocol is conditional, it permits immediate enrollment of new
patients at the Company's existing study sites, subject to site IRB
approval. The Company intends to further modify the investigational
plan to clarify data analysis information, but does not expect that
these modifications will affect patient enrollment or data collection
under the revised protocol.
The ARTISAN- AF Study was unconditionally approved under an
investigational device exemption (IDE) by the FDA in October 2010 and
was originally designed to enroll 300 patients at 14 leading
hospitals, as a prospective, randomized study.
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.
"We are excited about the opportunity to continue testing Robotic
Navigation with the Hansen System", said Dr. Natale.
"I am very pleased that the FDA has approved the new protocol design
submitted by Hansen Medical", said Dr. Gallinghouse. "This will
greatly facilitate enrollment in the trial, and allow us to evaluate
clinical endpoints in an expedited fashion. I look forward to the
continuation of this critical study of ablation of atrial
fibrillation using robotic navigation."
"This study is an important step toward expanding our United States
labeling to include use of our Artisan family of control catheters
with our Sensei X Robotic System to navigate certain ablation
catheters, and we believe this will be a positive factor in the
growth of our US EP business given our expectation that the ARTISAN-AF study will enroll patients much more quickly than the previous
study design," 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 demonstrate
important benefits of our technology for both patients and the
physicians who treat them."
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(R) X Robotic Catheter System
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 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, Artisan Control Catheter and Artisan Extend(R)
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 are cleared by the U.S.
Food and Drug Administration for manipulation and 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
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 our Sensei Robotic System for
hospitals, patients and physicians, our expectation that we will
fulfill the FDA conditions to approval of our revised protocol and
that the conditional approval will be made unconditional; the speed
of enrollment of the ARTISAN AF Study under the revised protocol; and
our expectation that the study will achieve its endpoints and
demonstrate safety and effectiveness of our products for AF ablation
procedures. Important factors that could cause actual results to
differ materially from those indicated by such forward-looking
statements include, among others: failing to satisfy the FDA's
conditions to the revised protocol; failing to enroll patients in the
ARTISAN AF Study at an increased rate following revision of the
protocol; failure to obtain, or delays in obtaining, IRB approval of
the new study design at current or new study sites or to execute
clinical trial agreements with new sites; costs of carrying out the
Artisan AF Study; failure to achieve one more more study endpoints;
the occurrence of one or more adverse events involving our products
or any study subject; safety, engineering and regulatory challenges
related to our products; 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. 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 Artisan are registered trademarks, and Magellan
is a trademarks of Hansen Medical, Inc. in the United States and
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
FTI Consulting, Inc.
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