SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

February 05, 2015 09:00 ET

Hansen Medical Announces Expanded Protocol for the ARTISAN AF IDE Study

FDA Approves Inclusion of the Latest Technology for the Treatment of Atrial Fibrillation

MOUNTAIN VIEW, CA--(Marketwired - Feb 5, 2015) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced FDA approval of an expanded protocol for the ARTISAN-AF IDE Study. The amended protocol now includes the use of the Thermocool® SmartTouch® Catheter (BioSense Webster, Diamond Bar, CA) and the EnSite Velocity Cardiac Mapping System (St. Jude Medical, St. Paul, MN). These technologies are used in conjunction with the Sensei® Robotic System to complete ablation procedures for the treatment of paroxysmal atrial fibrillation per the IDE study protocol.

"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," said 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. "Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients."

Research has shown that the quality of ablation lesions 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 control of the Sensei system have the potential to improve 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 platform technology that enables electrophysiology procedures. It is important to keep pace with innovation in our field," said Cary Vance, Hansen Medical President and CEO. "By including innovative technologies in our clinical studies, we hope to offer even more benefit to physicians and patients."

The ARTISAN AF Trial is a prospective, single arm study of the Hansen Medical Sensei Robotic System for introducing and positioning certain irrigated radio frequency (RF) ablation catheters in patients with atrial fibrillation. The trial will enroll patients with symptomatic, drug-refractory paroxysmal atrial fibrillation and evaluate robotic technique for the ablation of atrial fibrillation. There are two primary endpoints: safety, defined as the absence of early onset of all major adverse events, and efficacy, defined as freedom from atrial fibrillation through one year.

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 Sensei® Robotic System

Sensei Robotic 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 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 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 www.hansenmedical.com.

Forward-Looking Statements

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.

1. Ullah, W et al. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. PACE 2014;doi:10.1111/pace.12501.

2. GlobalData, Electrophysiology - Global Analysis and Market Forecasts, March 2014

"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. "EnSite Velocity" is a trademark of St. Jude Medical in the U.S. and other countries.