Hansen Medical Announces World's First Clinical Cases With New
Magellan(TM) 6Fr Robotic Catheter
Initial Clinical Experience to Be Presented at GEST 2014
Meeting, May 1 - 4, in San Francisco
MOUNTAIN VIEW, CA--(Marketwired - Apr 29, 2014) -
Hansen Medical, Inc. (NASDAQ: HNSN), announced today
the successful completion of the world's first clinical procedures
using the Magellan™ 6Fr Robotic Catheter. Professor Marc Sapoval,
MD, PhD and Dr. Olivier Pellerin, MD, MSc treated three patients
with the 6Fr catheter over the span of two days at Hôpital Européen
Georges Pompidou (APHP). The cases included two Uterine Fibroid
Embolizations and a Transarterial Chemoembolization (TACE)
procedure for liver metastasis of colon cancer.
The three cases performed last week were the first in a 25
patient study at Pompidou Hospital (APHP) 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, and
enables use of the Magellan Robotic System in smaller vessels in
the peripheral vasculature. The Magellan 6Fr Robotic Catheter
and accessories have received 510(k) clearance in the US, and are
pending CE Mark.
"We are pleased to have completed the world's first procedures
with the Magellan 6Fr Catheter. With this study, we will explore
the use of Intravascular Robotics in a wide variety of peripheral
vascular embolization procedures, including therapies involving
cancer treatment and women's and men's health," explained Professor
Sapoval. "Navigation with this robotic catheter is very controlled,
particularly in tortuous anatomy; and the Magellan Robotic System
provided an extremely stable platform to support the precise and
targeted delivery of therapeutic agents."
"Today's announcement is an important milestone for Hansen
Medical. The Magellan 6Fr Robotic Catheter will enable physicians
to apply the benefits of robotic precision, control and procedural
predictability to the treatment of many more vascular patients,"
said Chris Lowe, Interim CEO of Hansen Medical. "We are
pleased to partner with Pompidou Hospital (APHP) as part of our
shared commitment to improve the care of patients through the
application of advanced technologies. These successful initial
cases help to lay the foundation for the use of the Magellan system
in embolization procedures."
Hansen Medical to Present Magellan™ 6Fr Robotic Catheter at the
Global Embolization Symposium and Technologies (GEST) 2014 U.S.
Meeting
Hansen will be conducting product demonstrations with the new
Magellan 6Fr Robotic Catheter at the Global Embolization Symposium
and Technologies (GEST) 2014 U.S. Meeting at the San Francisco
Marriott Marquis May 1 - 4 at Booth 210. Prof Sapoval will discuss
his initial clinical experiences with Magellan on Thursday, May 1
at 10:40am in a talk titled "Robotic Assisted Embolization: Early
Human Experience." Prof Sapoval's presentation will be held during
Parallel Session I: Navigation and New Imaging Tools in the Yerba
Buena Ballroom.
Additionally, Olivier Pellerin, MD (Hôpital Pompidou) and
Mohamad Hamady, MD (St. Mary's Hospital in London) will share their
clinical experiences with the Magellan Robotic System at a
breakfast symposium at 7:00am on Saturday, May 3 titled "Clinical
Update on Robotic Assisted Embolization: What You Need to
Know."
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 Annual Report on
Form 10-K for the year ended December 31, 2014 filed with the SEC
on March 13, 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 443.213.0500 Email Contact
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Hansen Medical, Inc. (MM) (NASDAQ:HNSN)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024