Healthcare Industry News: Sensei X
News Release - February 28, 2012
Michael L. Eagle Appointed to Hansen Medical's Board of DirectorsFormer Medical Device and Pharmaceutical Executive Brings Additional Commercial and Operational Expertise to Company's Board
MOUNTAIN VIEW, CA--(Healthcare Sales & Marketing Network)- Hansen Medical, Inc. (NASDAQ: HNSN ), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced changes to its board of directors. Effective immediately, Michael L. Eagle has been appointed as a Director, following the resignation of Joseph M. Mandato as a Director.
Mr. Eagle has a rich history of operational, commercial and manufacturing experience. He served as Vice President of Global Manufacturing for Eli Lilly and Company from 1994 to 2001. During his tenure, he was responsible for global production, quality, engineering, facilities, distribution, environmental conditions and safety. Mr. Eagle joined Lilly in 1983 when Lilly acquired Advanced Cardiovascular Systems where he was Sr. Vice President of Operations. Later he served as President and CEO of IVAC Corporation and Vice President of the Vascular Intervention, Medical Devices and Diagnostics Division where he oversaw the operations of four medical device subsidiaries, a technology development center and the medical device and diagnostics businesses in Japan. He served as Vice President of Pharmaceutical Manufacturing prior to his most recent position.
Prior to his term at Lilly, Mr. Eagle was General Manager of Plastics Processing at IMED Corporation. Since retiring from Lilly, he has served as the founding member of Barnard Life Sciences, LLC -- a healthcare consulting company.
Mr. Eagle has served as a Director of a number of boards of both public and private healthcare companies including Micrus Endovascular, Inc. and Perclose, Inc. He currently serves on the boards of Cadence Pharmaceuticals and Somaxon Pharmaceuticals.
"I am pleased to join the Hansen board at such an important time for the company. I look forward to assisting the company in its mission to become the global leader in flexible robotics," commented Mr. Eagle on his appointment.
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® X Robotic Catheter System and Artisan Control Catheter were cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in electrophysiology (EP) procedures. This robotic catheter system 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 X System and Artisan Control Catheter 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 X System and Artisan Control Catheter are cleared for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. The Company's Magellan™ Robotic System, NorthStar™ Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone conformity assessment and CE marking and are commercially available in the European Union. In the U.S., the Magellan™ Robotic System, the NorthStar™ Robotic Catheter and accessories are the subject of a current filing with the FDA and are not commercially available. Additional information can be found at www.hansenmedical.com.
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, expectations, objectives, milestones and future events. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "expects," "potential," "believes," goal," "estimate," "anticipates," and similar words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances and other factors that may cause actual results to differ materially from the information expressed or implied by forward-looking statements made in this press release. Examples of such statements include statements about the potential timing of FDA clearance of our Magellan™ Robotic System in the US, the potential benefits of our Magellan Robotic System on the vascular procedures and the timing of commercializing our Magellan Robotic System, and anticipated growth in the adoption of the Sensei platform for electrophysiology procedures. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: engineering, regulatory and sales challenges in developing new products and entering new markets; potential safety and regulatory issues that could slow or suspend our sales; the uncertain timelines, costs and results of pre-clinical and clinical trials; the rate of adoption of our systems and the rate of use of our catheters; the scope and validity of intellectual property rights applicable to our products; competition from other companies; our ability to recruit and retain key personnel; our ability to maintain our remedial actions over previously reported material weaknesses in internal controls over financial reporting; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 filed with the SEC on November 7, 2011 and the risks discussed in our other reports filed with the SEC. 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 (Logo), Hansen Medical (with 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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