MOUNTAIN VIEW, CA — (Marketwired) — 09/17/14 — A study, published online ahead of print in , concluded that using Hansen Medical, Inc.–s (NASDAQ: HNSN) Sensei® Robotic System with the Thermocool® SmartTouch® Catheter (BioSense Webster, Diamond Bar, CA) for persistent atrial fibrillation is associated with statistically significant improved success rates when compared with manual ablation with Thermocool SmartTouch. The study found that a combination of remote robotic navigation (RRN), using Sensei, and catheter-based contact force sensing (CFS) using Thermocool SmartTouch, is associated with improved 12 month success rates (64% versus 36%, p=0.01) and shorter fluoroscopy times (41% reduction, p < 0.0005) than Manual/CFS ablation. There were no significant differences in rates of major or minor complications or procedure time.
“Prior research has shown that adequate contact between the catheter tip and heart tissue during ablation leads to improved patient outcomes,” said lead investigator Prof. Richard Schilling, M.D., FRCP, Barts Health NHS trust, London. “Results from our study found ablation with Sensei to be associated with higher and more stable contact force. These are very compelling data for Sensei, as it translated to significant benefit for patient outcomes compared with manual ablation.”
Prof. Richard Schilling and his colleagues conducted the study to compare remote robotic navigation, using Sensei, and Manual CFS ablation. Investigators performed a retrospective analysis of 200 patients with persistent atrial fibrillation across six hospitals in the United Kingdom and South Africa.
“These are very promising results for Sensei,” said Cary Vance, President and Chief Executive Officer of Hansen Medical. “Hansen–s vision is to develop technology that enables physicians to deliver enhanced patient care, and we are excited about Sensei–s potential to improve patient outcomes for ablation procedures.”
Cardiac arrhythmias are abnormal electrical signals in the heart. Atrial fibrillation is the most common form of cardiac arrhythmia, affecting nearly 3 million people in the United States alone. In radiofrequency catheter ablation, a catheter is inserted into left atrium and radiofrequency energy is delivered to the heart tissue to create scars, which are intended to block erratic electrical impulses so the left atrium can beat normally.
Research has shown that the quality of scar tissue is based on a combination of the contact between the catheter tip and heart wall, the power of the applied radiofrequency energy, and the amount of time the energy is applied. The Thermocool SmartTouch contact force sensing ablation catheter provides an objective measure of contact for optimal lesion creation. The stability and precision of the Sensei catheter have the potential to improve contact between the catheter tip and heart wall.
Sensei X Robotic Catheter System combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 14,000 patients, and is powered by a robotically controlled arm that allows for catheter navigation, stability and positioning within the patient–s heart atria. The Sensei X Robotic Catheter System, control catheters and accessories are intended to facilitate manipulation, positioning and control of Hansen Medical–s robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using specified percutaneous mapping catheters. The Sensei System is powered by a robotically controlled arm that allows for catheter navigation and stability. The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established.
Hansen Medical, Inc., based in Mountain View, California, is a global leader in Intravascular Robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company–s Magellan Robotic System, 9Fr Magellan Robotic Catheter, Magellan 6Fr Robotic Catheter, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Company–s mission is to enable Cardiac Arrhythmia and Endovascular Procedures and to improve patient outcomes through the use of Intravascular Robotics. Additional information can be found at .
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 other 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 regarding the potential benefits of our robotic systems for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: factors relating to engineering, regulatory, manufacturing, sales and customer service challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and economic conditions on capital spending by our potential customers; the rate of adoption of our systems and the rate of use of our catheters; our ability to manage expenses and cash flow, and obtain adequate financing; and other risks more fully described in the “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2013, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. 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.
“Artisan Extend,” “Hansen Medical,” “Hansen Medical (with Heart Design),” “Heart Design (Logo),” “Sensei,” “Lynx,” “Artisan,” “Instinctive Motion,” “Fine Force Technology,” “IntelliSense” are registered trademarks, and “Magellan” and “Hansen Medical Magellan” are trademarks of Hansen Medical, Inc. in the U.S. and other countries.
“SmartTouch” is a trademark of BioSense Webster, Inc. in the U.S. and other countries.
Chris Lowe
Interim Chief Financial Officer
Hansen Medical, Inc.
650.404.5800
Mark Klausner or Mike Piccinino, CFA
443.213.0500
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