Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics and the developer of robotic technology for
accurate 3D control of catheter movement, today announced that it
has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its Magellan™ Robotic System, including
the catheter and accessories. The Company will commence
commercialization at selected centers in the U.S. immediately, with
a full launch expected later in the year. The product will be
presented at the 66th Vascular Annual Meeting of the Society for
Vascular Surgery at National Harbor, Maryland from June 7-9.
The Magellan Robotic System is intended to facilitate navigation
to anatomical targets in the peripheral vasculature and
subsequently provide a conduit for manual placement of therapeutic
devices. The System has the potential to provide vascular surgeons
and other interventionalists the ability to perform fast and
predictable procedures, while allowing the physician to be seated
comfortably away from the radiation source, which may reduce
radiation exposure and physician fatigue.
"Today's announcement marks one of the most significant
milestones in the Company's history," said Hansen Medical President
and CEO Bruce Barclay. "Not only does the Magellan System have the
potential to be a significant growth driver for Hansen, it also
represents a fundamental step forward in the transformation of
vascular intervention using intravascular robotics."
The global vascular market is large and expanding rapidly,
driven by an aging population, the prevalence of diabetes and
obesity, and an increase in disease awareness. Of the more than 3
million vascular procedures done worldwide each year, approximately
one-third to one-half of them could be addressed using the Magellan
Robotic System.
Dr. Alan Lumsden, Chair of Hansen Medical's U.S. Scientific
Advisory Board, and Chair of the Department of Cardiovascular
Surgery and Medical Director of Methodist DeBakey Heart and
Vascular Center at The Methodist Hospital, Houston, commented, "The
Magellan Robotic System is a significant technological advancement
that may offer important clinical benefits for physicians
performing peripheral interventions. The System provides physicians
with independent robotic control of both catheter tips to navigate
efficiently through a variety of anatomies and lesions. Our in
vitro and in vivo animal studies indicate that using this platform
has the potential to increase efficiencies in the interventional
lab by shortening procedure times and allowing more predictable
interventions. Ultimately, we believe this System may facilitate
alternative patient treatment options by enabling robotic
endovascular interventions."
The Magellan Robotic System results in a new standard for
peripheral vascular intervention that has the potential to deliver
revolutionary lesion access, precise distal tip control, solid
catheter stability and consistent procedural efficiency.
Dr. Jean Bismuth, a leading vascular surgeon at the DeBakey
Heart and Vascular Center at The Methodist Hospital, Houston, said,
"Since the Magellan Robotic System was designed specifically for
vascular interventions, it offers excellent catheter stability and
precision during the delivery and placement of a variety of
therapeutic devices in different anatomic conditions, including
various peripheral vascular diseases with tortuous anatomy.
Additionally, the Magellan Robotic System may offer physicians less
radiation exposure and reduced procedural fatigue due to the remote
workstation that allows the physician to be seated comfortably
outside the imaging suite."
The Company believes the Magellan platform also provides a
compelling value proposition to hospitals.
"Hospitals today need to ensure not only quality patient care,
but also sound fiduciary judgment in all purchase decisions,"
continued Barclay. "To remain competitive in the markets they
serve, hospitals need to become more efficient, while also
increasing their patient capacity. The Magellan Robotic System has
the potential to help hospitals accomplish both of these
goals."
"We are excited about the initial interest a number of key U.S.
hospitals have shown in the Magellan System and intend to focus our
near-term commercialization strategy on partnering with a select
group of esteemed physicians who are both influential and early
adopters of new technologies in the industry," said Barclay. "We
will provide them with the appropriate training and engage with
them to demonstrate the benefit and value of the Magellan. This
focused and controlled commercial launch should enable us to
generate positive clinical experiences and data to drive both
interest and adoption among other physicians and hospitals in the
large and rapidly expanding U.S. peripheral vascular market, and
will be followed later this year with full launch activities."
Barclay concluded, "Today's announcement is a testament to the
immensely talented development and support teams at Hansen Medical
that worked tirelessly to reach this important milestone, and I
want to personally congratulate and thank them for their hard
work."
The Magellan System received a CE Mark in the European Union
last year, and the Company has already commenced a commercial
launch in that region. In addition, the System has been approved in
Australia, and is pending approval in Canada.
About the Magellan™ Robotic System Hansen
Medical's Magellan Robotic System is based upon the flexible
robotic technology incorporated in the Sensei-X® Robotic Catheter
System currently sold in the U.S. and Europe, which has been used
in more than 8,000 patients, but includes a number of key
enhancements. In particular, the Magellan Robotic System:
- Provides solid catheter stability for placement of therapeutic
devices.
- Is designed to enable predictable procedure times and increased
case throughput.
- Allows for independent, individual robotic control of the
distal tips of both the outer sheath and the inner leader catheter,
as well as robotic manipulation of standard guidewires.
- Is designed to allow for sufficient extension inside the body
to access hard to reach peripheral anatomy.
- Preserves the open architecture featured in the Sensei System
to allow for the subsequent use of many 6F therapeutic devices on
the market today.
- Is designed to potentially reduce physician radiation exposure
and fatigue by employing a remote physician workstation.
Hansen Medical Conference Call Company
management will hold a conference call to discuss the receipt of
510(k) clearance for the Magellan Robotic System today, June 4,
2012, at 2:00 p.m. Pacific (5:00 p.m. Eastern). Investors are
invited to listen to the call live via the Internet using the link
available within the "Investor Relations" section of Hansen
Medical's website at http://www.hansenmedical.com/. Additionally,
participants can dial into the live conference call by calling
877-941-1427 or 480-629-9664. An audio replay of the webcast will
be available approximately one hour after the completion of the
conference call through June 11, 2012, by calling 877-870-5176 or
858-384-5517, and entering access code 4544736.
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® X Robotic Catheter System and
Artisan Control Catheter were cleared by the U.S. Food and Drug
Administration for manipulation and control of certain mapping
catheters in electrophysiology (EP) procedures. This robotic
catheter system 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 X System and Artisan Control Catheter
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 X System and Artisan
Control Catheter are cleared for use during EP procedures, such as
guiding catheters in the treatment of AF, and the Lynx® Robotic
Ablation Catheter is cleared for the treatment of AF. The Company's
Magellan™ Robotic System, NorthStar™ 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.
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," 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 Magellan Robotic System on the vascular procedures
and the timing and results of commercializing our Magellan Robotic
System. Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
include, among others: engineering, regulatory and sales challenges
in developing new products and entering new markets; potential
safety and regulatory issues that could slow or suspend our sales;
the uncertain timelines, costs and results of pre-clinical and
clinical trials; 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;
the effect of credit, financial and economic conditions on capital
spending by our potential customers; our ability to manage expenses
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, 2012 filed with the SEC
on May 7, 2012 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 available.
Hansen Medical, Heart Design (Logo), Hansen Medical (with Heart
Design), and Sensei are registered trademarks, and Magellan is a
trademark of Hansen Medical, Inc. in the United States and other
countries.
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
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