Healthcare Industry News:  Sensei 

Devices Interventional Cardiology FDA

 News Release - November 1, 2010

U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of Hansen Medical Sensei(R) X Robotic Catheter System for Treatment of Atrial Fibrillation

MOUNTAIN VIEW, CA--(Healthcare Sales & Marketing Network) - Hansen Medical, Inc. (NASDAQ:HNSN ),a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it has received unconditional Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) authorizing a clinical trial to investigate the use of the Sensei® X Robotic Catheter System and the Artisan™ Control Catheter for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia. The trial was conditionally approved earlier this year as announced in a Hansen Medical press release on May 12, 2010.

"This comparative study is an important milestone toward our goal of expanding the universe of patients that benefit from robot assisted AF procedures," said Hansen Medical President and CEO Bruce Barclay. "We are encouraged and gratified by the prestigious medical centers and physicians that are or have expressed interest in participating in the trial, and we believe that the study results will provide an important comparative assessment of the use of robotic technology for this application."

Conditional approval for the trial was granted by the FDA in May, and under that approval, the first cases in the ARTISAN AF Trial have been completed by site principal investigator Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center and his team. The principal investigator of the full trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive director for TCAI.

Designed to enroll up to 300 patients at 14 leading hospitals, the ARTISAN AF Trial is a prospective, randomized study of the Hansen Medical Sensei X System for introducing and positioning the Biosense Webster NAVISTAR® THERMOCOOL® 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. The study will track 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. The trial protocol recommends that the IntelliSense® 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.

Atrial Fibrillation is the most common cardiac arrhythmia, and it 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.

About Hansen Medical, Inc.

Hansen Medical, Inc., based in Mountain View, California, develops products and technology using robotics for the accurate positioning, manipulation and control of catheters and catheter-based technologies. The company's Sensei® system and its Sensei X Robotic Catheter System were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. The flexible robotic platform is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei and Sensei X systems 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 and the Sensei X systems are cleared for use during EP procedures, such as guiding catheters in the treatment of AF. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements

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. Examples of such statements include statements about the potential effects of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on August 6, 2010. 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.

Hansen Medical, Heart Design, Hansen Medical & Heart Design, and Sensei are registered trademarks of Hansen Medical, Inc. in the United States and other countries.


Source: Hansen Medical

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