Healthcare Industry News: Ablation Catheter
News Release - June 13, 2007
Hansen Medical Announces First U.S. Customer Shipment to Cleveland Clinic
New Sensei Robotic Catheter System Enhances Physicians' Ability to Access Hard-to-Reach Anatomy Within Heart ChambersMOUNTAIN VIEW, CA--(Healthcare Sales & Marketing Network)--Jun 13, 2007 -- Hansen Medical, Inc. (NasdaqGM:HNSN ) announced today that it has shipped its first Sensei(TM) Robotic Catheter System and Artisan(TM) Control Catheters in the United States to the Cleveland Clinic in Ohio. The Cleveland Clinic is also one of the first Centers of Excellence for Hansen Medical, where training and research will take place under the guidance of world renowned physician, Andrea Natale, M.D., director of the Electrophysiology Lab and co-section head of Pacing and Electrophysiology.
"Since we received Food & Drug Administration clearance in May, there has been tremendous market interest, which we believe provides us with great momentum for potential sales of the Sensei system," said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical. "We are especially pleased to be working closely with the Cleveland Clinic to gather data from clinical cases to further demonstrate the benefits of this robotically controlled catheter technology."
The Sensei System, which was also installed at two institutions in Europe -- St. Mary's Hospital in London and the Institute for Clinical and Experimental Medicine in Prague, Czech Republic -- has already been incorporated into clinical practice for use during the treatment of complex cardiac diseases at these institutions. The Sensei system and Artisan catheter have received CE Mark approval in the European Union for use during cardiac ablation procedures.
"We are pleased to have the Sensei system at the Cleveland Clinic," said Dr. Natale. "I have been evaluating Hansen's system for approximately four years, and we will incorporate use of the new technology in our daily practice."
The Sensei system, which is designed to allow physicians to place mapping catheters in hard-to-reach anatomical locations within the heart easily, accurately and with stability during the diagnostic phase of complex cardiac arrhythmia treatment, is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. The two main components that comprise the system are the Artisan control catheter and an ergonomically designed, remotely placed workstation where the physician is seated throughout each procedure. In addition to lessening operator fatigue, the remote workstation creates a virtual shield for physicians against harmful radiation.
The open architecture provided by the Sensei system, which allows the use of pre-approved catheters from third-party manufacturers, requires a labeling addition from the FDA. The addition is intended to remind physicians that the safety and effectiveness of the system 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, based in Mountain View, Calif., was founded in 2002 to develop products and technology using robotics for the accurate positioning, manipulation and stable control of catheters and catheter-based technologies. Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about the potential for success and timing of sales in the United States and Europe of the Sensei System and Artisan Control Catheter. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including potential safety issues; the scope of potential use of our products; the scope and validity of intellectual rights applicable to our products; competition from other companies; our ability to obtain additional financing to support our operations; our ability to successfully launch and market our product; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10Q for the quarter ended March 31, 2007. 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 has pending trademark applications for "Hansen Medical," "Sensei," "Artisan," "Hansen Artisan," as well as the Hansen Medical "heart design" logo.
Source: Hansen Medical
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