SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

April 29, 2010 08:30 ET

Studies Show Increased Safety and Substantial Reduction in Harmful Radiation to Patient With Sensei Robotic System

One Study Reports 63% Less Radiation Dose and 44% Less Fluoroscopy Time

MOUNTAIN VIEW, CA--(Marketwire - April 29, 2010) -  Hansen Medical, Inc. (NASDAQ: HNSN) announced compelling results from three independent clinical studies showing that use of the Sensei® system in procedures for atrial fibrillation (AF) and other abnormal heart rhythms reduced patients' exposure to harmful cancer causing radiation by 63 percent, and provided stable, precise catheter control with equivalent safety to non-robotic (manual) procedures. The studies were designed to compare use of the Sensei system in patients with AF to manual technique in terms of success, complication rates, procedure time, and radiation exposure to patient and physician. All of these studies reported substantial reduction in x-ray exposure to the patient and physician, as well as similar safety and success relative to manual technique.

Radiation safety has become a critical international issue, specifically patients' exposure to radiation for long periods of time. According to the U.S. Food & Drug Administration (FDA), radiation exposure is associated with the development of cancer, irreversible eye damage and genetic defects. Cardiac catheterization labs have long been considered high radiation dose areas due to the period of fluoroscopy required for procedures. Results from these three studies offer valuable information to hospitals, particularly as it relates to lower diagnostic x-ray exposure during cardiac procedures, and the results may help clinicians decrease x-ray radiation to physicians and patients.

One single center study, performed at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, showed substantial decrease in radiation dose during complex cardiac procedures using the Sensei system.

"In our clinical experience, robotic navigation of catheters in patients with atrial fibrillation (AF) with the Sensei system was safe, effective, and associated with shorter procedural and fluoroscopic times than conventional manual technique," said Josef Kautzner, M.D., Ph.D., F.E.S.C., Head, Department of Cardiology, IKEM. "I was able to complete procedures in under 10 minutes of fluoroscopy time, which is a 44 percent reduction from standard procedures. In addition, radiation dose to the patient was reduced by 63 percent. Both of these results are extremely important findings that will help to improve patient and physician safety."

In a U.S. study, published in the Journal of Cardiovascular Electrophysiology, results showed that use of robotic catheter navigation during procedures in patients with AF reduced radiation exposure time by 10 minutes compared to manual technique. The study also demonstrated a low 1.7 percent complication rate, which is equivalent to the rate reported in the non-robotic group. The 390-patient, single center study was performed at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin.

"The most important contribution we can make to our patients is to ensure their safety while under our care," said Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive medical director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. "Our study with the Hansen Medical Sensei Robotic Catheter System aligns with our efforts on many fronts. With this technology, studies have shown a statistically significant reduction in x-ray exposure, which is extremely important for patients with atrial fibrillation. In addition, the remote robotic manipulation system offers an opportunity to overcome the limitations of manual control, and it provides accurate and stable positioning, which may improve procedures for patients with atrial fibrillation."

Most recently, an independent clinical study of 60 patients was performed in the Department of Electrophysiology at the Heart Center University Hospital Hamburg-Eppendorf (UKE), in Germany. Again, results showed significant reduction in x-ray time during atrial fibrillation (AF) procedures using the Sensei robotic navigation system.

"Our objective was to investigate the influence of robotic navigation combined with 3D mapping on the x-ray exposure to physician and patient during a paroxysmal AF procedure in a prospective randomized trial," said Daniel Steven, M.D., UKE. "The resulting data underscored that procedures in patients with paroxysmal AF can be performed safely and reliably using the Sensei system.

"Furthermore, use of the Sensei system not only decreases operators' fluoroscopy exposure, but also minimizes overall fluoroscopy time to the patient. Our results show x-ray with robotic navigation was reduced significantly per procedure -- from 22 minutes with conventional technique to nine minutes with the robot."

"The results of these three independent studies clearly demonstrate the safety and value of our Sensei system, and the critically important role this robotic navigation system can play in the reduction of radiation and fluoroscopy exposure," said Frederic Moll, M.D., president and CEO, Hansen Medical. "Radiation protection is a primary concern for physicians and patients, and we believe the safety profile for the Sensei system is contributing significantly to improved patient care, as evidenced by the low rate of complications, and the ability of our system to reduce x-ray exposure."

The Sensei Robotic Catheter System allows physicians to instinctively position robotic catheters in difficult anatomical locations within the heart in a stable and controlled manner. The system consists of a physician workstation capable of controlling a robotic arm, which is attached near the foot of the procedure table. The robotic arm maneuvers the Artisan™ Control Catheter.

Manual ablation requires a physician to stand at the patient's bedside next to an x-ray radiation source and perform a series of complex manual manipulations inside a patient's heart.

According to the American College of Cardiology, the American Heart Association and the European Society of Cardiology, it is estimated that atrial fibrillation (AF) affects more than two million Americans and 4.5 million Europeans. The number of patients with AF is expected to increase even more due to an aging population, a rising number of people with chronic heart disease and improved diagnostic technologies. Additionally, 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.

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® 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.

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.

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

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