SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

July 06, 2015 09:15 ET

Hansen Medical® Announces Successful Enrollment of Initial Cohort in Artisan® U.S. Clinical Trial

MOUNTAIN VIEW, CA--(Marketwired - Jul 6, 2015) -  Hansen Medical®, Inc. (NASDAQ: HNSN), the global leader in intravascular robotics, today announced it has completed enrollment in the initial evaluable cohort of the ARTISAN® clinical trial.

The ARTISAN Atrial Fibrillation Trial is a prospective, single-arm, multi-center, US and OUS study designed to evaluate the safety and effectiveness of the Sensei® Robotic System and Artisan family of catheters for introducing and positioning specified commercially available RF ablation catheters in subjects with symptomatic, drug-refractory paroxysmal atrial fibrillation. The Bayesian designed study requires enrollment of an initial cohort of 125 patients, with subsequent enrollment permitted to support the end-point analysis. The trial has 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.

"We are excited to see the initial phase of enrollment completed in the IDE and are working closely with the investigators and FDA to expand the clinical indications for the Artisan catheter in the U.S. market. This patient cohort sets the initial timing to evaluate the trial endpoints and gain additional clinical indications in the U.S." said Cary Vance, President and Chief Executive Officer of Hansen Medical. "We believe our robotic technology brings enhanced control and predictability to these procedures, and addresses serious occupational hazards faced by physicians and their teams in the delivery of patient care."

"This clinical trial is significant and sets a milestone for robotic technology in the treatment of patients with atrial fibrillation "said Dr. Joseph Gallinghouse, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. "The team here at St. David's finds the Sensei Robotic System reduces radiation exposure to the operator, while the Artisan catheter predictably navigates and provides a stable platform during AF ablation, a procedure which can sometimes last for hours." Dr. Gallinghouse has significant experience with the Sensei Robotic System and Artisan catheter and has performed more than 1,200 procedures to date. 

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 the 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 over 17,000 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, 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)," "Heart Design (Logo)," "Sensei," and "Artisan" are registered trademarks, and "Magellan" is a trademark, of Hansen Medical, Inc. in the U.S. and other countries.

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, 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.