MOUNTAIN VIEW, CA—(Marketwired – Feb 1, 2016) – Hansen Medical, Inc. (
), the global leader in intravascular robotics, today announced the latest publication in the Journal of Cardiac Electrophysiology: Analysis of catheter contact force during atrial fibrillation ablation, using the robotic navigation system: results from a randomized study.
The purpose of this study, led by Dr. Antonio Dello Russo and Dr. Claudio Tondo of the Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino in Milan, Italy, was to evaluate catheter contact force (CF) measurements both with and without the use of Sensei® X robotic navigation system (RNS) during pulmonary vein isolation (PVI) procedures. The study evaluated eighty patients with symptomatic atrial fibrillation (AF). Fifty–seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter.
Atrial fibrillation ablation was performed successfully in all patients without complications, CF and the 1–year freedom from AF recurrence was higher in the RNS group while this same group was observed to have a significant reduction in fluoroscopy time (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05).
Dr. Joe Gallinghouse, M.D., Cardiac Electrophysiologist at St. David's Medical Center in Austin, Texas and Principal Investigator of the ARTISAN AF IDE Study previously stated, “There is a substantial amount of innovation in the treatment of atrial fibrillation for catheter ablation, including distal tip contact force sensing catheters like SmartTouch. Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients.” The company recently completed enrollment in the ARTISAN AF IDE Study designed to support the expansion of the company's current labeling in the U.S. beyond mapping.
The research from Cardiologico Monzino in Milan, Italy continues to support the quality of the ablation lesions 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 stability and control of the Sensei system improves the contact between the catheter tip and heart wall1. The EnSite Velocity Mapping System facilitates 3D navigation of catheters in the heart atria. Sensei's CoHesion feature offers physicians excellent catheter control by integrating the EnSite Velocity 3D map into the navigation function of Sensei's physician workstation.
“The Sensei Robotic System is a key technology which enables electrophysiology procedures. The results from the team at Cardiologico Monzino in Milan prove the need for this critical technology,” said Cary Vance, Hansen Medical President and CEO. “By continuing to innovate technologies, more and more physicians have the ability to achieve these types of results, ultimately providing the patients with perfected outcomes.”
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 alone2. 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.
About the Sensei® Robotic System
The Sensei Robotic System combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in thousands of 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 Robotic 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 Robotic 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.
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the 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, Magellan Robotic Catheters, 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 www.hansenmedical.com.
“Hansen Medical,” “Hansen Medical (with Heart Design),” and “Heart Design (Logo)” are registered trademarks, and “Magellan” and “Hansen Medical Magellan” are trademarks of Hansen Medical, Inc. in the U.S. and other countries. All other trademarks are the property of their respective owners.
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, 2014, 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.