Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in
intravascular robotics, and Royal Philips (NYSE: PHG) (AEX: PHIA)
today announced that they have reached an important milestone in
their long-term collaboration by securing certified compatibility
-- article 12 of the Medical Device Directive 93/42/EEC, as amended
by 2007/47/EC -- between Hansen Medical's Magellan™ Robotic System
and Philips' Allura interventional X-ray systems. Article 12
compatibility covers specific technical and service requirements,
and means that the Magellan Robotic System is compatible with
Philips' Allura live image-guidance systems when used according to
instructions.
The Magellan Robotic System uses advanced technology to navigate
peripheral vessels. The Magellan System's proprietary robotic
catheter technology is designed to deliver stability and distal tip
control of a catheter and sheath, as well as robotic control of
standard guidewires. When using the Magellan System, the physician
is seated away from the radiation source and can perform key
elements of the procedure while seated comfortably in a
centralized, remote workstation.
Philips began collaborating with Hansen Medical on the
development of the Magellan Robotic System in 2010. Hansen Medical
subsequently received CE-marking for the system in 2011 and 510(k)
clearance from the US Food and Drug Administration (FDA) in
mid-2012.
"We are pleased to secure this important certification with
Philips, our longstanding imaging partner for our robotic systems,"
said Bruce Barclay, President and CEO of Hansen Medical. "Article
12 compatibility ensures seamless coordination and integration of
the Magellan Robotic System with Philips' most advanced live-image
guidance systems for our hospital and physician customers, enabling
greater access to innovative solutions."
As a leader in image-guided interventions and therapies, Philips
offers a comprehensive portfolio that includes hybrid operating
room solutions and live-imaging solutions, plus advanced navigation
and interventional tools that work seamlessly with them. The
company has multi-year development programs and collaborations with
leading innovators to improve existing minimally-invasive
procedures and enable new ones.
"In addition to improving patient outcomes, Philips is committed
to reducing the cost and increasing the speed and safety of
image-guided interventions and therapies through collaboration and
meaningful innovation," said Bert van Meurs, Senior Vice President,
General Manager Integrated Clinical Solutions & Marketing at
Imaging Systems, Philips Healthcare. "We believe that
robotic-assisted interventional techniques have great potential,
which is why we have been collaborating with Hansen Medical for
many years now. We continue to strive for seamless integration of
our own and our partners' innovations to deliver meaningful
clinical solutions for our customers."
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 over 10,000 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.
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™
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. In the European
Union, the Company's Sensei® X Robotic Catheter System and Artisan
Control Catheter 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 Control Catheter were 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 www.hansenmedical.com.
About Royal Philips: Royal Philips (NYSE:
PHG) (AEX: PHIA) is a diversified health and well-being company,
focused on improving people's lives through meaningful innovation
in the areas of Healthcare, Consumer Lifestyle and Lighting.
Headquartered in the Netherlands, Philips posted 2012 sales of EUR
24.8 billion and employs approximately 116,000 employees with sales
and services in more than 100 countries. The company is a leader in
cardiac care, acute care and home healthcare, energy efficient
lighting solutions and new lighting applications, as well as male
shaving and grooming and oral healthcare. News from Philips is
located at www.philips.com/newscenter.
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 about
the potential benefits of our Magellan Robotic System for
hospitals, patients and physicians, and the anticipated timing of
commercially launching a 6F vascular catheter. Important factors
that could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others:
engineering, regulatory, manufacturing, sales and customer service
challenges in developing new products and entering new markets; the
commercial viability of our products in the 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. 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), Sensei and Lynx are registered trademarks, and Magellan is
a trademark of Hansen Medical, Inc. in the United States and other
countries.
For further information, please contact: Hansen
Medical: Investor Contacts: Peter J. Mariani Chief Financial
Officer Hansen Medical Inc. Tel: +1 650.404.5800 Brian Ritchie FTI
Consulting, Inc. Tel: +1 212.850.5683 E-mail: Email Contact John
Capodanno FTI Consulting, Inc. Tel: +1 212.850.5705 E-mail: Email
Contact Philips: Rachel Bloom-Baglin Philips Healthcare Tel:
+1 978 7609007 E-mail: Email Contact Steve Klink Philips Corporate
Communications Tel.: +31 6 10888824 E-mail: Email Contact
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