MOUNTAIN VIEW, CA--(Marketwire - May 03, 2012) - 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 the Sensei® X Robotic Catheter System at the Heart Rhythm Society's 33rd Annual Scientific Sessions from May 9-12, 2012 in Boston. The Company will also be showcasing an upcoming software release for the Sensei X Robotic Catheter System at Booth 465.
This upcoming software release will include an updated CoHesion™ Module which combines the accuracy of 3D catheter control with the visual guidance of 3D electroanatomical mapping, a synergistic technology combination that realizes the potential of instinctive motion. It also will achieve compatibility and integration with St. Jude Medical's EnSite Velocity 3.0 Cardiac Mapping System, recently released by St. Jude Medical. In addition, the software will include changes to the user interface which allows electrophysiologists (EPs) to perform instinctive 3D catheter control when using other 3D mapping systems without the CoHesion Module, specifically Biosense Webster's CARTO™ Navigation System.
"The majority of our customers are currently using either CARTO or Ensite Velocity 3D mapping systems when performing EP procedures, and in both cases, physicians will have control of both the robotic catheter as well as the orientation of the 3D map at the Sensei X physician workstation, allowing instinctive 3D control," said Bruce Barclay, President and CEO of Hansen Medical. "Gone are the days when the EP can only control the manual catheter and has to call out instructions to a technologist at the 3D mapping system to change the map orientation for him. We are pleased with the technological advances we have made to enable 3D catheter control with greater ease."
Other highlights of the Heart Rhythm Society's Scientific Sessions include:
- Dr. Andrea Natale, executive director at the St. David's Texas Cardiac Arrhythmia Institute in Austin, Texas will speak about the Sensei X Robotic Catheter System in a presentation entitled "Magnetic and Robotic Navigation Systems: Have Our Dreams Been Realized?" at the Seaport World Trade Center on Wednesday, May 9, 2012, 8:00 AM - 9:35 AM
- Professor Michael Mangrum, M.D. will discuss his clinical experience using the Sensei X Robotic Catheter System in a presentation entitled "Remote and Robotic Technology: Does it Work?" in Room 210A on Thursday, May 10, 2012, 11:00 AM -11:30 AM
About Sensei® X Robotic Catheter System
Through 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:
- Catheter Stability with Force-Sensing
- Instinctive 3D Control
- Reduced Fluoro Time for Physician
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 and is currently under investigation in a multi-center IDE study. The U.S. product labeling 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.
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, expectations, 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," "anticipates," 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 anticipated growth of Hansen's flexible robotic technology in both EP and vascular applications and statements about the anticipated timing of regulatory clearances, including 510(k) clearance in the United States. 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 Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on March 15, 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 of Hansen Medical, Inc. in the United States and other countries.