SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

April 27, 2011 16:01 ET

Hansen Medical to Highlight New Products and Data at the Heart Rhythm Society Meeting

Company Products Exhibited in the Heart Rhythm 2011 "Networked EP Lab"

MOUNTAIN VIEW, CA--(Marketwire - Apr 27, 2011) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will showcase new products and data at the Heart Rhythm Society's 32nd Annual Scientific Sessions from May 4-7, 2011 at the Moscone Center in San Francisco. The Company will be exhibiting all of its new and commercially available products, including the Lynx® Robotic Ablation Catheter that was recently launched in Europe, at Booth #1020.

The Lynx Ablation Catheter is a low profile, flexible all-in-one irrigated ablation catheter and therapy system that provides many of the benefits of the Artisan Extend™ Control Catheter with enhanced flexibility and ease-of-use benefits over competitive atrial fibrillation (AF) treatments. Professor Richard Schilling, M.B., B.S., FRCP, M.D., Consultant Cardiologist at London Bridge Hospital (UK), said, "The Lynx irrigated ablation catheter is an ideal catheter for the treatment of paroxysmal AF as it appears to have greater flexibility and range of movement than other commercially available ablation catheters." The catheter obtained CE Mark approval in 2010 and was released commercially throughout Europe earlier this year. The catheter is not approved for use in the United States.

"We are encouraged by our growing EP business as evidenced by the record procedure growth and catheter sales we delivered in 2010, and we look forward to building on that positive momentum at this important meeting," said Bruce Barclay, President and CEO of Hansen Medical. "Our record EP procedural growth and greater than 5,000 clinical cases testify to the continued market adoption, safety and clinical relevance of our Sensei® X system and the value that it delivers to patients, physicians, hospitals and payors. The early clinical results from our Lynx Ablation Catheter have been positive, making the success of the Lynx Ablation Catheter in Europe, and eventually the U.S., an important part of our plan to develop and market proprietary products that provide us greater potential for increasing market share and higher margins. We look forward to exhibiting this new catheter and its benefits to a broad segment of European electrophysiologists at this important international meeting."

Other highlights of the Scientific Sessions include:

  • Hansen Medical's remote navigation robotics system will be featured within the "Networked EP Lab" at Heart Rhythm 2011. This new program for 2011 aims to showcase state-of-the art technology and demonstrate the integration of the latest tools and team processes.

  • A recently published case study from a U.S. community hospital in Cardiovascular Business will be featured at the Hansen Medical booth. This case study describes how an arrhythmia program was developed to fulfill an unmet community and patient need. Use of flexible robotics resulted in a 70%+ improvement in left atrial EP patient volume. Daily case capacity was optimized, which allowed for an increase in device volume and resulted in an increase in the total number of EP patients that were seen at this hospital. In addition, with the center's first-year experience it improved its anticipated first year pro forma net present value for the robotics system from $1.5 million to over $2 million.

  • Dr. Donald Rubenstein from Greenville Memorial Hospital in Greenville, South Carolina will present "Integration of 3D Rotational Angiography, Mapping and Robotic Catheter Steering: Clinical Benefits and Workflow" within the Networked EP Lab presentation theatre on Thursday, May 5, from 10:00-10:25 am.

  • Professor Richard Schilling will discuss his clinical experience using the Sensei X robotic system in the "Meet the Experts" session scheduled on Friday, May 6, from 12:15-1:15 pm.

  • Hansen will be hosting hands on demonstrations for physicians of both the Artisan Extend Control Catheter and Lynx Robotic Ablation Catheter, which work with Hansen Medical's Sensei® X Robotic Catheter System. This advanced system allows physicians to reach more difficult-to-access anatomy while retaining the stability needed for delicate cardiac arrhythmia procedures.

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® system and its Sensei X Robotic Catheter System 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 and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established during EP procedures, such as guiding catheters in the treatment of AF. In the European Union, the Sensei and the Sensei X systems 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.

Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "goal," "potential," "expects," and similar words. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements about the potential benefits of our products and their acceptance into the marketplace. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Annual Report on Form 10-K filed with the SEC on March 16, 2011. 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), Lynx and Sensei are registered trademarks, and Artisan is a trademark, of Hansen Medical, Inc. in the United States and other countries.

Contact Information

  • Investor Contacts:
    Peter Osborne
    Interim CFO
    Hansen Medical
    650.404.5800

    Matt Clawson
    Allen & Caron Inc
    949.474.4300
    Email Contact