MOUNTAIN VIEW, CA — (Marketwire) — 01/06/12 — Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will showcase its Sensei® X Robotic Catheter System at the 17th Annual Boston Atrial Fibrillation Symposium from January 12-14 at the Seaport Hotel and World Trade Center in Boston. The Company will be exhibiting the Sensei X Robotic Catheter System and related products at Booth #309.
The Sensei X Robotic Catheter System is a flexible robotic platform that integrates advanced catheter control with 3D visualization, designed to provide catheter stability with force sensing, instinctive and precise catheter placement, as well as reduced radiation for both physician and patient. At the conference, physicians will be able to experience the ability to perform true 3D catheter mapping and driving with a functional Sensei X Robotic Catheter System, fully integrated to a St. Jude Medical EnSite 3D Mapping System. There will also be two additional Demo Kiosks where physicians can practice catheter mapping and driving in virtual simulation.
“When physicians experience the truly instinctive nature of the 3D catheter control and visualization offered by the Sensei X Robotic Catheter System, they will see the great potential of this robotic catheter system in patient care,” said Bruce Barclay, Hansen Medical-s president and CEO. “We continue to see increasing momentum in the adoption of the Sensei X Robotic Catheter System by a new generation of electrophysiologists, who are embracing new and innovative solutions in order to provide improved care for their patients and to grow their practices.”
“We continue to improve our world class education and training program which is designed to provide physicians and their staff with the ability to use the system with confidence and precision in a shorter period of time. Physicians will be able to see and experience the training we offer at the Boston Atrial Fibrillation Symposium,” Barclay concluded.
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 and Precise Catheter Placement Control
Reduced Radiation for Physician and Patient
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, which is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, has undergone conformity assessment and CE marking and is commercially available in the European Union. The NorthStar Robotic Catheter and related accessories designed for use with the Magellan Robotic System are also CE marked. In the U.S., the Magellan Robotic System, the NorthStar Robotic Catheter and accessories are the subject of a pending 510(k) with the FDA and are not commercially available. Additional information can be found at .
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 forward looking statements include statements about the anticipated growth in adoption of the Sensei platform for electrophysiology procedures, the potential benefits of the Magellan Robotic System on the vascular procedures, and expected availability of catheters in multiple lengths. 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; 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), Sensei, and Artisan are registered trademarks, and Magellan and NorthStar are trademarks of Hansen Medical, Inc. in the United States and other countries.
Peter J. Mariani
Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Sharrifah Al-Salem, CFA
415.293.4414
John Capodanno
212.850.5705
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