Hansen Medical Announces First Clinical Cases in United States With New Magellan(TM) 6Fr Robotic Catheter
28 5월 2014 - 10:00PM
Marketwired
Hansen Medical Announces First Clinical Cases in United States With
New Magellan(TM) 6Fr Robotic Catheter
MOUNTAIN VIEW, CA--(Marketwired - May 28, 2014) - Hansen
Medical, Inc. (NASDAQ: HNSN), a global leader in Intravascular
Robotics, today announced the successful completion of the first
clinical procedures in the United States using the Magellan™ 6Fr
Robotic Catheter. Alan Lumsden, MD, treated two patients with the
6Fr Catheter at Houston Methodist Hospital in Houston, TX. The
cases included an endovascular aneurism repair (EVAR) to treat an
abdominal aortic aneurysm and a lower extremity intervention for
the treatment of peripheral artery disease.
These procedures at Houston Methodist follow last month's
successful completion of the world's first clinical procedures
using the Magellan 6Fr Robotic Catheter at Hôpital Européen Georges
Pompidou in Paris, France. The Pompidou procedures were part of an
ongoing, 25 patient study to assess the use of the new Magellan 6Fr
Robotic Catheter in a variety of embolization procedures.
The Magellan 6Fr Robotic Catheter is the latest addition to the
growing family of catheters for use with the Magellan Robotic
System. The 6Fr Catheter's design provides for precise robotic
navigation and control in a single, 6Fr outer diameter catheter;
enabling use of the Magellan Robotic System in smaller vessels in
the peripheral vasculature.
"I am very pleased to have completed the first clinical
procedures in the United States using the 6Fr Robotic Catheter,"
explained Dr. Lumsden. "As an existing user of the Magellan 9Fr
Robotic Catheter, our team is very familiar with the Magellan
Robotic System. The lower profile 6Fr catheter enables robotic
procedures with a smaller access puncture. Further, the smaller
diameter makes it likely to be very valuable for lower limb
procedures, particularly when encountering tortuous anatomy."
"These initial cases in the United States and Europe demonstrate
the potential for the Magellan 6Fr Catheter to expand the
utilization of the Magellan Robotic System to treat a broader set
of endovascular conditions, including smaller-vessel procedures,"
said Cary Vance, CEO of Hansen Medical. "We are very pleased by our
partnership with Houston Methodist and are eager to continue our
collaboration in the ongoing evaluation of this new catheter."
About the Magellan™ Robotic System Hansen Medical's Magellan
Robotic System is intended to be used to facilitate navigation in
the peripheral vasculature and subsequently provide a conduit for
manual placement of therapeutic devices. The Magellan Robotic
System is designed to deliver improved predictability, control and
catheter stability to endovascular procedures. Since its commercial
introduction in the U.S. and Europe, the Magellan Robotic System
has demonstrated its clinical versatility in many cases in a broad
variety of peripheral vascular procedure types in centers across
the U.S. and Europe. The Magellan Robotic System offers several
important features including:
- Provides improved predictability, control and catheter
stability as a physician navigates a patient's peripheral
vasculature and then provides a conduit for manual treatment of
vascular disease with standard therapeutic devices.
- Is designed to enable more predictable procedure times and
increased case throughput potentially allowing hospitals to improve
utilization within their vascular business line
- Employs an open architecture designed to allow for the
subsequent use of many therapeutic devices on the market
today.
- Is designed to potentially reduce physician radiation exposure
and fatigue by allowing the physician to navigate procedures while
seated comfortably at a remote workstation away from the radiation
field and without wearing heavy lead as required in conventional
endovascular procedures.
- The Magellan 9Fr Robotic Catheter for independent, robotic
control of the distal tip of two telescoping catheters (an outer
Guide and an inner Leader catheter), as well as robotic
manipulation of standard guidewires.
- The Magellan 6Fr Robotic Catheter allows for independent
robotic control of two separate bend sites on a single catheter, as
well as robotic manipulation of standard guidewires. This smaller
catheter design may be preferred by certain physicians who prefer a
smaller diameter vessel access site, or in procedures in smaller
vessels.
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, Magellan™ 6Fr Robotic
Catheter, and related accessories are intended to facilitate
navigation to anatomical targets in the peripheral vasculature and
subsequently provide a conduit for manual placement of therapeutic
devices. The Magellan 9Fr Robotic Catheter has undergone both CE
marking and 510(k) clearance and is commercially available in the
European Union, and the U.S. The Magellan 6Fr Robotic Catheter has
undergone 510(k) clearance in the U.S. and is in limited release
for the next several months in anticipation of more wide-scale
commercially availability later in 2014. 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
potential benefits of our robotic systems for hospitals, patients
and physicians. 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; potential safety and
regulatory issues that could slow or suspend our sales; the effect
of credit, financial and 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 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, 2014 filed with the SEC
on May 9, 2014 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.
"Artisan Extend," "Hansen Medical," "Hansen Medical (with Heart
Design)," "Heart Design (Logo)," "Sensei," "Lynx," "Artisan,"
"Instinctive Motion," "Fine Force Technology," "IntelliSense" are
registered trademarks, and "Magellan" and "Hansen Medical Magellan"
are trademarks of Hansen Medical, Inc. in the U.S. and other
countries.
Investor Contacts: Peter J. Mariani Chief Financial Officer
Hansen Medical, Inc. 650.404.5800 Westwicke Partners, LLC. Mark
Klausner or Mike Piccinino, CFA 443.213.0501 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
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