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Hospital Acquires Hansen Medical Vascular Robotic System to Conduct Preclinical Endovascular Research

Thu, 02/09/2012 - 11:45am
The Associated Press

(http://www.hansenmedical.com)

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible

robotics and the developer of robotic technology for accurate 3D

control of catheter movement, and the Center for Education, Simulation

and Innovation (CESI) at Hartford Hospital in Hartford, Connecticut,

today announced that Hartford Hospital has purchased a preclinical

vascular robotic system from Hansen Medical for the purpose of

conducting advanced preclinical endovascular research.

"We are very pleased with the addition of a Hansen Medical vascular

robotic system dedicated to preclinical vascular investigation. This

solidifies our position as pioneers in medical training," said Dr.

Steven Shichman, Medical Director of Center for Simulation, Education

and Innovation (CESI) and Chair of Peri-operative Services at Hartford

Hospital. "It is our intention to create an institutional focus on

endovascular and cardiovascular robotics. Our robotic technology

capability, which now includes two Sensei robots, has positioned us to

become one of the leading endovascular and cardiovascular robotics

programs in the world."

"In January, Hansen Medical selected Hartford Hospital to be a Center

of Excellence for the SENSEI@ X Robotic Catheter System based on the

institution's strong reputation for providing complex and innovative

care and its renowned excellence in patient care, teaching and

research," said Bruce Barclay, Hansen Medical's President and CEO.

"This additional investment in a Hansen Medical vascular robotic

system for the purpose of conducting preclinical vascular research

reflects their further confidence in the potential benefits of Hansen

Medical's advanced flexible robotic technology."

About the Hansen Medical Vascular Robotic SystemThe Hansen Medical

vascular 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 7,000 patients with

cardiac arrhythmia, but includes a number of key enhancements. In

particular, the vascular robotic system:

In 2010, the Company announced the completion of its First-in-Man

study in Europe, during which 20 endovascular procedures were

successfully performed utilizing an earlier version of the vascular

robotic system, demonstrating its potential to allow physicians to

effectively treat peripheral vascular disease, while lessening

radiation exposure.

In Europe, the company has received CE mark approval for a vascular

robotic system know as the Magellan Robotic System, the NorthStar

Robotic Catheter and related accessories. In the U.S., the Magellan

Robotic System requires U.S. Food & Drug Administration (FDA)

clearance, and a 510(k) application is currently pending. As such, the

products are not commercially available in the U.S.

About Sensei@X Robotic Catheter SystemThrough continued advancement of

medical robotics, Hansen Medical has developed a next generation

minimally-invasive, robotic catheter system, the Sensei X Robotic

Catheter System which combines advanced levels of 3D catheter control

and 3D visualization. This unique, state of the art technology is

powered by a highly accurate, robotically controlled arm that allows

for catheter navigation, stability and positioning within the

patient's heart, allowing for the following system advantages:

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@ 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 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

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 atrial fibrillation (AF),

have not been established. In the European Union, the Sensei X System

and Artisan Control Catheter are cleared for use during EP procedures,

such as guiding catheters in the treatment of AF, and the Lynx@

Robotic Ablation Catheter is cleared for the treatment of AF. 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 conformity assessment and CE marking and are commercially

available in the European Union. In the U.S., the Magellan Robotic

System, the NorthStar Robotic Catheter and accessories are the

subject of a current filing with the FDA and are not commercially

available. Additional information can be found at

www.hansenmedical.com(http://ctt.marketwire.com/?release849297&id1243126&type1&urlhttp%3a%2f%2fwww.hansenmedical.com%2f).

About Hartford HospitalHartford Hospital, founded in 1854, is one of

the largest teaching hospitals and tertiary care centers in New

England with one of the region's busiest surgery practices. It is

annually ranked among America's Best Hospitals by US News & World

Report and has been recognized nationally for the quality of many of

its programs, including cardiology, cancer, stroke and joint and spine

care. The 867-bed regional referral center provides high-quality care

in all clinical disciplines. Among its divisions is The Institute of

Living, a 114-bed mental health facility with a national and

international reputation of excellence. Jefferson House, a 104-bed

long-term care facility, is also a special division of Hartford

Hospital. The hospital's major centers of clinical excellence include

cardiology, oncology, emergency services and trauma, mental health,

women's health, orthopedics, bloodless surgery and advanced organ

transplantation. Hartford Hospital owns and operates the state's only

air ambulance system, LIFE STAR.

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 statements include statements about anticipated growth in

adoption of the Sensei platform for electrophysiology procedures, the

potential timing of FDA clearance of our vascular robotic system in

the US, the timing of first cases to be performed with the Magellan

System, the potential benefits of our vascular robotic system on the

vascular procedures and the timing of commercializing our vascular

robotic system. Important factors that could cause actual results to

differ materially from those indicated by such forward-looking

statements include, among others: engineering, regulatory and sales

challenges in developing new products and entering new markets;

potential safety and regulatory issues that could slow or suspend our

sales; the uncertain timelines, costs and results of pre-clinical and

clinical trials; 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; the effect

of credit, financial and economic conditions on capital spending by

our potential customers; our ability to manage expenses 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 September 30, 2011 filed with the SEC on November 7,

2011 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), and Sensei are registered trademarks of Hansen Medical, Inc.

in the United States and other countries.

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