Hansen Medical Announces Worldwide Survey of AF Ablation with Robotic Navigation Presented at American Heart Association Meeting

London, November 30 (ots/PRNewswire) -

Multi-Center Procedure Data Presented in Over 1700 Cases Using
the Sensei(R) X Robotic Catheter System

Hansen Medical, UK Ltd, a subsidiary of Hansen Medical, Inc., , a
global leader in flexible robotics and the developer of robotic
technology for accurate 3D control of catheter movement, today
announced a new multi-center worldwide survey evaluating the safety
and efficacy of atrial fibrillation (AF) ablation by robotic
navigation with the Sensei(R) Robotic Catheter System. The abstract
was presented by Luigi Di Biase, MD, PhD, in a poster session (Poster
# 16602) at the American Heart Association Scientific Sessions 2011
at the Orange County Convention Center in Orlando, Florida on
November 14th, 2011.

The survey evaluated the safety and effectiveness of robotic
navigation. The overall complication rate across the entire survey
was a low 4.7%. After an average follow-up of 15 months, the success
rate (defined as freedom from atrial tachyarrhythmia off
antiarrhythmic drugs) of robotic procedures was slightly superior at
67% compared to that of manual procedures at 64%. Most compelling in
the survey data are the benefits that robotic navigation demonstrated
in both safety and efficacy as the electrophysiologist gained
experience with the Sensei(R) Robotic Catheter System and improved
their robotic techniques. The results of this survey, in addition to
the other known benefits physicians, patients and payers receive from
robotic navigation including less physician and patient radiation
exposure, shorter procedure times and less physician fatigue, help
establish the value of the Sensei(R) Robotic System for patients with
cardiac arrhythmias.

"Our survey data demonstrates that the Sensei(R) Robotic Catheter
System is a safe approach for the ablation of AF and has the
potential to lead to superior success rates, especially as centers
gain more experience with the System," said Dr. Di Biase.

The senior author of the abstract, Andrea Natale, M.D., F.A.C.C.,
F.H.R.S., F.E.S.C., executive director of the Texas Cardiac
Arrhythmia Institute at St. David's Medical Center in Austin, Texas
said, "This is an important survey, and it demonstrates the safety
and the efficacy of the Sensei(R) Robotic Catheter System."

"This comprehensive survey data as well as the numerous benefits
of our flexible catheter robotic system, such as reduced radiation
exposure, shorter procedure times and lower physician fatigue,
demonstrate the value of the Sensei(R) Robotic Catheter as an
alternative to manual procedures in arrhythmia patients," said Bruce
Barclay, Hansen Medical's president and CEO. "In particular, the data
showed the benefits derived in both safety and efficacy as operator
experience with the System increases; and, importantly, points to the
potential of replicating these successes in other centers through
improved training and the sharing of best practices."

Mr. Barclay also noted that "the data reported in this survey
includes procedures from the earliest clinical experiences with the
system. Since initial launch in 2007, Hansen and our physician
customers have gained significant experience and knowledge through
the more than 7,000 patient procedures that have been performed with
the system. During this time, physicians have developed advanced
robotic techniques while the company has made several product design
and feature enhancements including the Sensei(R)-X Robotic Catheter
System with advanced catheter control and visualization features,
improved mapping technology interfaces with our strategic partners -
St. Jude, Phillips, GE and Siemens- and the company's advanced
tactile feedback technology called IntelliSense(R) including
Intellisense Vibe and Flex functionality. "

"Also during this time, the company has developed a world class
education and training program designed to provide physicians and
their staff with the ability to use the system with confidence and
precision in a shorter period of time." Barclay concluded.

Under the survey, 1,728 patients with AF were treated with the
Sensei(R) Robotic Catheter System at 12 different sites, including
Texas Cardiac Arrhythmia Institute at St. David's Medical Center,
Methodist DeBakey Heart and Vascular Center, Houston, Texas and
Christiaan Barnard Memorial Hospital, Cape Town, South Africa, in the
US and internationally from June 2007 until December 2009. Patients
with all types of AF were used in the study with 39% of the patients
having either persistent (29%) or permanent (10%) AF, and the
remaining (61%) with paroxysmal AF. Cappato's Worldwide Survey (2010)
reporting on 16,309 AF patients was used for historical control of
manual ablation results. Cappato's Worldwide Survey is conducted
periodically by a group of prominent electrophysiologists and is
considered a leading resource for ablation efficacy and complications
by manual technique.

About the Sensei(R) X Robotic System and Artisan Control Catheter

In the Europe Union, the Sensei(R) X System and Artisan(R)
Control Catheter are cleared for use during EP procedures, such as
guiding catheters in the treatment of AF.

In the U.S., the Sensei(R) X Robotic Catheter System and
Accessories are intended to facilitate manipulation, positioning and
control of Hansen Medical's robotically steerable catheters for
collecting electrophysiological data within the heart atria with
electro-anatomic mapping and recording systems, using the following
percutaneous mapping catheters: the Polaris-Dx(TM) Steerable
Diagnostic catheters made by Boston Scientific Corporation and the
Livewire(TM) Electrophysiology catheters made by St. Jude Medical.

In the U.S., the safety and effectiveness of the Sensei(R) X
Robotic Catheter System and Accessories for use with cardiac ablation
catheters, in the treatment of cardiac arrhythmias including atrial
fibrillation, have not been established. Hansen Medical is conducting
a 300 patient, multiple site IDE study in the United States to
evaluate the performance of this device to facilitate manipulation,
positioning and control of Hansen Medical's robotically steerable
catheters (a) for collecting electrophysiological data within the
heart atria with electro-anatomic mapping and recording systems,
using the following percutaneous catheters: the Polaris-Dx(TM)
Steerable Diagnostic catheters made by Boston Scientific Corporation,
and the Livewire(TM) Electrophysiology catheters made by St. Jude
Medical, and (b) for manipulating the Navistar(TM) ThermoCool(TM)
Diagnostic/Ablation catheters made by Biosense Webster for the
treatment of drug refractory recurrent symptomatic paroxysmal atrial
fibrillation, when used with compatible three-dimensional mapping
systems. The study includes a seven-day follow-up for safety and a
one-year follow-up for efficacy at intervals of 90, 180, and 365
days.

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(R) X Robotic Catheter System and
Artisan(R) 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(R)
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(R) X System
and Artisan(R) 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(R) X System and Artisan(R) Control Catheter are cleared
for use during EP procedures, such as guiding catheters in the
treatment of AF, and the Lynx(R) Robotic Ablation Catheter is cleared
for the treatment of AF. The Company's Magellan(TM) Robotic System,
NorthStar(TM) 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 conformity
assessment and CE marking and are commercially available in the
European Union.

In the U.S., the Magellan(TM) Robotic System, the NorthStar(TM)
Robotic Catheter and accessories are the subject of a pending 510(k)
with the FDA and are not commercially available. Additional
information can be found at http://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 forward-looking statements include, but are not limited to,
statements about the expected timing of regulatory submissions,
approvals, clearances, and commercialization of our robotic systems
and catheters, the market potential for our products, the expected
sales and utilization levels for our products, and the potential
benefits of our products in the treatment of patients. Important
factors that could cause actual results to differ materially from
those indicated by forward-looking statements include, among others:
potential safety and regulatory issues that could delay, suspend or
terminate clinical studies, regulatory approvals or sales; challenges
in designing, engineering and manufacturing systems and catheters to
function as intended; uncertain timelines, costs and results of
clinical trials and the development of new products; the scope and
validity of intellectual property rights applicable to our products;
competition from other companies; our ability to maintain our
remedial actions over previously reported material weaknesses in
internal controls over financial reporting; and the effect of credit,
financial and economic conditions on capital spending by our
potential customers. These and other risks are described in greater
detail under the heading "Risk Factors" contained in our Quarterly
Report on Form 10-Q filed with the SEC on November 11, 2011 and our
other periodic SEC filings. 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, Artisan, Lynx and IntelliSense are registered
trademarks, and Magellan, NorthStar are trademarks of Hansen Medical,
Inc. in the United States and other countries. All other trademarks
are the property of their respective owners.

ots Originaltext: Hansen Medical, Inc
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Investor Contacts: Dr. Roland Peplinski, General Manager, EMEA,
AP & Canada, Hansen Medical, UK Ltd, +44-20-7393-1905. Toby Minton,
+44-(0)7921762293