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Company to Commence Initial Commercial Launch in the United States Immediately

Wed, 06/06/2012 - 12:45pm
The Associated Press

(http://www.hansenmedical.com)

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

robotics and the developer of robotic technology for accurate 3D

control of catheter movement, today announced it will exhibit its

Magellan? Robotic System at the 2012 Vascular Annual Meeting@ of the

Society for Vascular Surgery@ from June 7-9 at Gaylord National Resort

& Convention Center in National Harbor, MD. The Company recently

announced receipt of 510(k) clearance from the U.S. Food and Drug

Administration for the Magellan Robotic System, including the catheter

and accessories, and will commence initial launch activities in the

U.S. immediately.

The Magellan Robotic System is designed to simplify and enhance

catheter navigation and therapeutic intervention through a variety of

clinical cases in the peripheral vasculature. The Magellan Robotic

System results in a new standard for peripheral vascular intervention

with the potential to deliver revolutionary lesion access, precise

distal tip control, solid catheter stability and consistent procedural

efficiency.

"We are excited to showcase our Magellan Robotic System at this

important annual meeting of leading vascular surgeons, as we believe

this product has the potential to enhance the way physicians navigate

the vasculature based on the clinical and pre-clinical work completed

to date and feedback from a number of leading clinicians worldwide,"

said Bruce Barclay, President and CEO of Hansen Medical. "The robotic

system and robotic catheter give physicians maximum flexibility and

control through independent distal tip control of a catheter and a

sheath, as well as through robotic manipulation of a standard

guidewire from a centralized, remote workstation. Moreover, this

proprietary technology is designed to deliver predictable catheter

navigation of peripheral vessels."

The Company will be exhibiting the Magellan Robotic System and

conducting product demonstrations at Booth 418.

In addition, Jean Bismuth, M.D., of the DeBakey Heart & Vascular

Center, Methodist Hospital in Houston, will be present at Hansen

Medical's booth at 2:00 p.m. on Thursday, June 7th, to conduct product

demonstrations and to share his experience using the Magellan Robotic

System with other physicians in attendance.

"We are very pleased to have Dr. Bismuth, one of the pioneering

clinicians in the use of intravascular robotics in endovascular

procedures, spend time at our booth to conduct demonstrations of our

Magellan Robotic System and to share his preclinical experience using

our robotic catheter technology," Barclay added.

About the Magellan? Robotic SystemHansen Medical's Magellan 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 more than 8,000 patients, but includes

a number of key enhancements. In particular, the Magellan Robotic

System:

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 both CE marking and 510(k) clearance and are commercially

available in the European Union, and the U.S.

Additional information can be found at

www.hansenmedical.com(http://ctt.marketwire.com/?release=896103&id=1687240&type=1&url=http%3a%2f%2fwww.hansenmedical.com%2f).

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, the potential benefits of

our Magellan Robotic System on the vascular procedures and the timing

and results of commercializing our Magellan 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 March 31, 2012 filed with

the SEC on May 7, 2012 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, and Magellan is a

trademark of Hansen Medical, Inc. in the United States and other

countries.

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