SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

January 06, 2011 16:01 ET

Hansen Medical to Highlight New Lynx™ Robotic Ablation Catheter, Other New Products at the Boston Atrial Fibrillation Symposium

Company Expanding Target Market Beyond Core Robotic Navigation Technology

MOUNTAIN VIEW, CA--(Marketwire - January 6, 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 its new Lynx™ Robotic Ablation Catheter and other innovative new products at the 16th Annual Boston Atrial Fibrillation Symposium from January 13-15 at the Seaport Hotel and World Trade Center in Boston. The Company will be exhibiting all of its new and commercially available products at Booth #304.

The Lynx Robotic Ablation Catheter is a small profile, flexible irrigated ablation catheter that offers stability and accuracy during the treatment of atrial fibrillation (AF) and other electrophysiology disorders. The catheter obtained CE Mark approval in July, 2010 and, following a limited release in late 2010, will be fully released commercially throughout Europe this month. The catheter is not approved for use in the United States.

"The Lynx Robotic Ablation Catheter includes a proprietary irrigated RF ablation tip, demonstrating Hansen Medical's strategy to expand its target market beyond its core robotic navigation technology," said Bruce J Barclay, President and CEO of Hansen Medical. "The early clinical results of our limited release of the Lynx Ablation Catheter last quarter 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 are looking forward to exhibiting this new catheter and its benefits to a broad segment of European electrophysiologists at this important Symposium."

The Lynx Robotic Ablation Catheter is a smaller profile, more flexible all-in-one catheter and therapy system that provides many of the benefits of the Artisan™ robotic catheter while allowing for improved flexibility and ease-of-use benefits over other solutions for treating AF. Professor Richard Schilling, M.B., B.S., F.R.C.P., 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."

Other highlights of the Symposium include:

  • A presentation by Luigi DiBiasi, M.D., based on the results of his clinical experience with the Lynx Robotic Ablation Catheter in a poster abstract titled, "Preliminary acute results of Robotic Catheter Ablation of Atrial Fibrillation utilizing the Lynx Robotic Catheter System in humans: safety and feasibility." 
  • Hands on demonstrations for physicians of the Company's Artisan Extend™ Control Catheter, which works with Hansen Medical's proprietary Sensei® X Robotic Catheter System and provides advanced navigational capabilities compared to the original Artisan catheter. This advanced system allows physicians to reach more difficult-to-access parts of the 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. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Hansen's results to differ materially from those expressed or implied by such 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 "potential," "plan" 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 for increasing market share and higher margins based on the early results of the Lynx Robotic Ablation Catheter, and the expected timing and scope of the full commercial release of the Lynx Ablation Catheter in Europe. 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 to function as intended, uncertain timelines, costs and results of clinical trials and development of new products, our ability to plan and manage cost-reduction or operational efficiency initiatives, the scope and validity of intellectual property rights applicable to products being developed, and our ability to remediate material weaknesses in internal controls over financial reporting. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on November 9, 2010. 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, Hansen Medical & Heart Design, and Sensei are registered trademarks, and Artisan and Lynx are trademarks, 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