Healthcare Industry News: SENSEI
News Release - May 10, 2007
Hansen Medical Launches Sensei Robotic Catheter System and Artisan Control Catheter at Heart Rhythm Society's Scientific SessionsCompany Recently Received FDA Clearance to Commercialize First Generation Robotic Platform for Catheter Mapping Procedures
DENVER, CO--(Healthcare Sales & Marketing Network)--May 10, 2007 -- HRS Booth #940 -- Hansen Medical, Inc. (NasdaqGM:HNSN ) will launch the Sensei(TM) Robotic Catheter System and Artisan(TM) Control Catheter, designed to facilitate manipulation, positioning and control of mapping catheters during electrophysiology (EP) procedures, here at the Heart Rhythm Society's 28th Annual Scientific Sessions. The company recently announced U.S. Food & Drug Administration (FDA) clearance to commercialize the first generation robotic platform, as well as joint development and co-marketing agreements with St. Jude Medical, a global leader of EP technology. The company also announced initial shipments of SENSEI systems into the European market, as well as the establishment of its first Centers of Excellence to support training and demonstration activities. The Centers are located at St. Mary's Hospital in London and the Cleveland Clinic Foundation in Ohio, both under the guidance of world renowned electrophysiologists Wyn Davies, M.D., in London and Andrea Natale, M.D., in Cleveland
"We are thrilled to be heading to the Heart Rhythm Society meeting with both FDA clearance and joint development and co-marketing agreements with St. Jude Medical accomplished," said Frederic Moll, M.D., founder and chief executive officer of Hansen Medical, Inc. "Both of these achievements will allow Hansen Medical to begin executing its marketing strategy, and we are anticipating rapid adoption of this technique in the treatment of complex cardiac diseases.
"Our direct sales force in the United States and our European representative with direct sales responsibility in the United Kingdom and Benelux countries have already begun to see positive results from the relationships they have with leading hospitals."
The SENSEI system and Artisan catheter are 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.
"The SENSEI system offers accuracy and control in a flexible platform for navigation during complex catheter mapping procedures," said Wyn Davies, M.D., FRCP, FHRS, consultant cardiologist, St. Mary's Hospital, London, the company's first Center of Excellence. "The new robotic system allows the operator to perform EP procedures in a more consistent fashion, which I believe will lead to the development of a standard approach for complex diseases."
As the trend from open surgical procedures to less invasive percutaneous procedures continues, tools that facilitate access to critical anatomy are needed so that physicians can more effectively and safely perform these complex procedures. Currently, a majority of clinicians continue to manually guide catheters through the heart to detect and treat a variety of cardiac arrhythmias. The technique 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. Achieving stable contact at anatomic sites within the heart, which is essential for successful mapping procedures, can be difficult. As a result, insufficient contact between the catheter tip and the inside of the heart wall can lead to highly variable and less than optimal procedure results for the patient. Hansen Medical believes its robotic platform overcomes these hurdles and will enable physicians to perform procedures that historically have been too difficult or time consuming to accomplish routinely with existing manual technique.
The SENSEI system 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. The SENSEI system has received CE mark approval in Europe, and the Artisan Control Catheter is currently pending CE mark approval.
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 Annual Report on Form 10K. 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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