Hansen Medical Showcases New Generation Robotic Catheter Technology at Boston Atrial Fibrillation Symposium.Company Announces Successful Completion of Clinical Trial for Sensei sen·sei n. pl. sen·seis 1. A judo or karate teacher. 2. A teacher or mentor. 3. Used as a form of address for such a person. Robotic Catheter System BOSTON -- Hansen Medical, Inc., (Nasdaq:HNSN HNSN Hansen Medical, Inc (Mountain View, California) ) will showcase its new generation robotic technology for accurate and stable control of catheter movement during cardiac procedures here at the 12th Annual Boston Atrial Fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF) Symposium, January 11-13, 2007. The Sensei[TM] Robotic Catheter System is designed to guide catheters for mapping heart anatomy during the treatment of patients suffering from abnormal heart rhythms, or arrhythmias. The company recently announced the successful completion of a 20-patient prospective trial and seven-day follow-up using the Sensei system to guide catheters for mapping heart anatomy, which is a critical step in identifying heart tissue that generates abnormal heart rhythms. Data from the follow-up showed no device-related adverse events, and is being prepared as part of a submission to the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in support of a 510(k) currently under review. "The new robotic catheter system has the potential to fundamentally change the way electrophysiology procedures are performed worldwide and make it possible for a broader group of physicians to perform complex cardiac procedures such as cardiac arrhythmia cardiac arrhythmia n. See cardiac dysrhythmia. Cardiac arrhythmia An irregular heart rate or rhythm. Mentioned in: Holter Monitoring, Stress Test cardiac arrhythmia mapping," said Wyn Davies Ronald Wyn Davies (born March 20, 1942 in Caernarfon, Gwynedd) is a former professional Welsh football player. Davies was the archetypal target man. With his well-developed aerial abilities he earned the nickname 'Wyn the Leap'. , M.D., FRCP FRCP Fellow of the Royal College of Physicians. FRCP abbr. Fellow of the Royal College of Physicians , FHRS, consultant cardiologist, St. Mary's Hospital, London, and principal investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences of the clinical trial. Currently, cardiac electrophysiology Cardiac electrophysiology is the science of the mechanisms, functions, and performance of the electrical activities of specific regions of the heart. This term is usually used in describing studies of such phenomena by invasive (intracardiac) recording of spontaneous activity as procedures are performed using a manual technique that requires physicians to perform a series of complex manipulations at one end of the catheter with inadequate assurance that the tip of the catheter will respond as desired while inside a patient's heart. As a result, achieving stable contact at every anatomic site within the heart necessary for successful mapping can be difficult. Insufficient contact between the catheter tip and the inside of the heart wall can lead to highly variable and less than optimal procedure outcomes. "There is a medical need for broader use of catheter-based procedures for diseases where catheters are rarely used today, and we believe our robotic platform will enable more physicians to perform complex interventional procedures through greater ease of use, and possibly improve patient outcomes," said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical. To date, 83 cardiac procedures have been performed on patients in Europe using the Sensei Robotic Catheter System. The new technology incorporates fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography , intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. ultrasound, 3D surface map and patient electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface. data into one portable workstation. The workstation can be easily moved among catheter lab suites and does not require costly construction of a specialized room. Hansen Medical anticipates that its proprietary system will enhance the ease-of-use and stability of catheter-based procedures by offering physicians better control over catheter placement, as well as potentially decrease procedure times and radiation exposure. 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. The Sensei system is currently under review for FDA clearance to guide catheters for mapping anatomy of the heart. 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 our clinical development results and whether the FDA will consider this sufficient and appropriate to support our planned 510(k) clearance. 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 Registration Statement on Form S-1. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. |
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