Magellan(TM) Robotic System to Be Featured in Live Case at Transcatheter Cardiovascular Therapeutics (TCT) Conference
29 10월 2013 - 5:01AM
Marketwired
Magellan(TM) Robotic System to Be Featured in Live Case at
Transcatheter Cardiovascular Therapeutics (TCT) Conference
MOUNTAIN VIEW, CA--(Marketwired - Oct 28, 2013) - Hansen
Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular
robotics, today announced that Dr. Barry Katzen, founder and
Medical Director of Baptist Cardiac & Vascular Institute
(Baptist Hospital of Miami), is scheduled to utilize the Magellan™
Robotic System in a live endovascular aneurysm repair (EVAR) case
at the Transcatheter Cardiovascular Therapeutics (TCT) conference
in the Main Arena II at the Moscone Center in San Francisco,
California on Wednesday, October 30th at 2:30 PM ET.
"Robotics offer the ability to achieve controlled catheter
delivery and the delivery of a device that is generally
significantly more precise and stable than a conventional sheath
for purposes of treatment," stated Dr. Katzen. "The use of robotics
in endovascular procedures has the potential to make procedures
safer, more effective and reduce the time procedures take to
complete, which would benefit patients, physicians and
hospitals."
"We are excited to, once again, have Dr. Katzen showcasing our
technology at TCT, which is the world's largest educational meeting
focused on interventional vascular procedures," said Bruce Barclay,
president and CEO of Hansen Medical. "We continue to build a
growing body of positive clinical data with the Magellan system,
and live cases such as this most recent procedure by Dr. Katzen
provide Hansen Medical with the opportunity to highlight to the
interventional vascular community how the Magellan system can
significantly enhance endovascular procedures."
About the Magellan™ Robotic System Hansen Medical's Magellan
Robotic System is intended to be used to facilitate navigation to
anatomical targets in the peripheral vasculature and subsequently
provide a conduit for manual placement of therapeutic devices. The
Magellan System is designed to deliver predictability to simple and
complex endovascular procedures. Since its commercial introduction
in the U.S. and Europe, the Magellan System has demonstrated its
clinical versatility in many cases in a broad variety of peripheral
vascular procedure types in centers across the US and Europe. The
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 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 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 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®
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 about the potential
benefits of our technology and the value of our intellectual
property portfolio. 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 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 June 30, 2013 filed with
the SEC on August 9, 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
and NorthStar are trademarks 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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