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|Hansen Medical Announces FDA Conditional IDE Approval for Evaluating Sensei X Robotic Catheter System for Treatment of Atrial Fibrillation|
MOUNTAIN VIEW, CA, May 12, 2010 (MARKETWIRE via COMTEX) --Hansen Medical, Inc. (NASDAQ: HNSN) announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) authorizing a clinical trial to investigate use of the Sensei(R) X Robotic Catheter System and the Artisan(TM) Control Catheter for treatment of Atrial Fibrillation (AF). The first case in the ARTISAN AF Trial, a pivotal clinical trial using the Sensei X system for the treatment of AF, was completed May 11, 2010 by Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center. The Principal Investigator of the trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive medical director for TCAI.
"As an early adopter of the Sensei technology, and an experienced electrophysiologist, I am very pleased to initiate this important study to advance the clinical understanding of this groundbreaking flexible robotic technology in the treatment of arrhythmias," said Dr. Natale.
Atrial Fibrillation, or AF, (the most common cardiac arrhythmia) affects an estimated 3.3 million Americans and 4.5 million Europeans. This number is expected to increase due to an aging population and a rising number of people with chronic heart disease. AF is associated with increased long-term risk for severe and disabling stroke, and it is estimated that 15-20 percent of strokes occur in people with AF(1).
The ARTISAN AF Trial is a prospective, randomized study of the Hansen Medical Sensei X System for introducing and positioning the Biosense Webster NAVISTAR(R) THERMOCOOL(R) Catheter in patients with AF. The trial will enroll patients with symptomatic, drug-refractory paroxysmal AF at a 2:1 ratio and evaluate robotic technique versus manual technique for the ablation of AF. There are two primary endpoints: Safety, defined as the absence of early onset of all major adverse events, and efficacy, defined as freedom from AF through one year. Up to 14 investigative sites worldwide will enroll 300 subjects. The trial protocol recommends that the IntelliSense(R) force sensing system be used to guide ablative lesion placement. The IntelliSense readings of 10-20g during ablation, with a maximum of 40g are recommended. The protocol also recommends that ablation is performed using irrigated radio frequency (RF) power settings of 20-25W with a maximum power of 30W, and a maximum temperature of 50 degrees Celsius. Additionally, data will be collected to compare the reduction in radiation exposure and the potential improvements in single-procedure success rates.
"We are enthusiastic about working closely with the FDA in executing this critical study," said Dan Wallace, co-founder and vice president of regulatory, clinical and advanced applications for Hansen Medical. "We believe this study will enable Hansen Medical to provide important data to clinicians regarding the utility of our technology in ablation of AF. In addition, we are privileged to have strong relationships with world renowned clinical leaders interested in taking part in this study under the guidance of our principal investigator and early visionary, Dr. Andrea Natale."
In order for physicians to participate in the ARTISAN AF Trial, he or she must have previously performed at least 20 procedures with the Sensei system. In addition, they must enroll at least two patients per month as a study investigator, and they need to have performed a minimum of 100 atrial fibrillation ablation procedures manually.
"My colleagues and I have completed more than 385 cases using the Sensei system and we are thrilled to be taking part in this timely and important study," said Dr. Gallinghouse. "In addition to evaluating safety and efficacy, this study design provides us an opportunity to investigate whether less radiation and RF energy is used robotically, compared to what may be typical with manual technique."
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, Calif., develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. Its first product, the Sensei(R) Robotic Catheter system, is a robotic navigation system that enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during complex cardiac arrhythmia procedures. The Sensei system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data and was cleared by the U.S. Food and Drug Administration (FDA) in May 2007 for manipulation and control of certain mapping catheters in Electrophysiology (EP) procedures. The safety and effectiveness of the Sensei system 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 system is cleared for use during EP procedures, such as guiding catheters in the treatment of AF. Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "believes," "goal," "estimate," and similar words. Hansen Medical intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995.
Hansen Medical, Heart Design, Hansen Medical & Heart Design, Sensei, IntelliSense, and Fine Force Technology are registered trademarks, and Artisan, Artisan Extend, Lynx, CoHesion, and Instinctive Motion are trademarks of Hansen Medical, Inc. in the United States and other countries.
Navistar and ThermoCool are registered trademarks of Biosense Webster.
(1) Source: The American College of Cardiology, the American Heart Association and the European Society of Cardiology.