September 3, 2008
Hansen Medical Announces World’s First Robotic Transvascular Aneurysm Repair
Hansen Medical, Inc. (NASDAQ: HNSN), the global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, announced today that a team of physicians led by Professor Nick Cheshire at St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust, in London, England, utilized Hansen Medical's Sensei(TM) Robotic Catheter System and Artisan(TM) Control Catheter to aid deployment of stent grafts used to treat an abdominal aortic aneurysm in a 78-year old patient. This procedure is believed to be the world's first in which any robotic medical technology has been used to repair an aortic aneurysm through a patient's vascular system.
"We have always believed vascular surgery would provide a very natural application for our Sensei and Artisan robotic technology, and the recent advancement at St. Mary's Hospital demonstrates what is already within reach for our technology in this field," said Fred Moll, M.D., co-founder and Chief Executive Officer of Hansen Medical. "Just as important, the recent experience of clinicians at St. Mary's Hospital clearly demonstrates what physicians can accomplish when they use Hansen Medical's advanced technology to provide more precise movement and control during different types of surgery."
"The time taken to correctly position a stent graft during the treatment of an aneurysm is highly variable and depends on the complexity of the vascular anatomy," explained Professor Nick Cheshire. "By providing increased catheter stability and accurate navigation, the Sensei system has the potential to greatly simplify the procedure and make it more predictable. In this case, it only took a few minutes to drive the Artisan catheter to the location where the stent was to be deployed."
The aorta is the largest artery in the human body. An abdominal aortic aneurysm results from weakening and swelling of the artery's walls, often as people age, and is frequently fatal if it ruptures. When positioned across the weakened section, stent grafts act as scaffolding that can help prevent the aneurysm from bursting. This surgery was performed through accessing the patient's vascular system at the groin and using Hansen Medical's Sensei system to accurately navigate the Artisan catheter up into the weakened section of the aorta, where the stent grafts were placed.
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, and for use in the treatment of any type of vascular disease, have not been established in the United States. In the European Union, the Sensei system and Artisan catheter are intended to facilitate medical procedures within the atria of the heart using percutaneous catheters introduced through the vascular system. Additional information can be found at www.hansenmedical.com.
Hansen Medical technology was recognized in March 2008 by Frost & Sullivan, and presented with the consulting company's 2008 Product Innovation Award in the field of U.S. Image-Guided and Robotic-Assisted Surgery Devices.
About Imperial College Healthcare NHS Trust
The Imperial College Healthcare NHS Trust comprises Charing Cross, Hammersmith Hospital, Queen Charlotte's & Chelsea, St. Mary's and Western Eye hospitals in London, England. It is the largest Trust in the UK, and in partnership with Imperial College London, is the UK's first Academic Health Science Centre (AHSC). The AHSC was created to take the research discoveries it makes and translate them into new and improved treatments and techniques to directly benefit patients throughout the Trust, the NHS and the rest of the world.
The Vascular Unit at St. Mary's Hospital in London is a leading European center for endovascular treatment with the largest number of endovascular thoracoabdominal aneurysm repairs worldwide. The Imperial College Endovascular Group has undertaken prize winning research into vascular robotics and won the 1st prize (scientific session) from the British Society of Endovascular Therapy in July 2008 (Riga CV, Bicknell CD, Hamady M, Cheshire NJW). For more details please visit www.imperial.nhs.uk.
This press release contains forward-looking statements regarding, among other things, statements relating to expectations, goals, plans, objectives and future events. We intend 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. Examples of such statements include statements about possible future applications of the company's technology in vascular surgery and the potential benefits of the company's technology in new applications. 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, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, the risks and uncertainties inherent in our business, including potential safety and regulatory issues that could slow or suspend our development of new products and applications; our ability to manage growth and focus on selected new applications; the scope and validity of intellectual property rights applicable to our products; competition from other companies; and our ability to obtain additional financing to support our operations. These and other risks are described in greater detail under the heading "Risk Factors" contained in our periodic SEC filings, including our Quarterly Report on Form 10-Q filed with the SEC on August 5, 2008. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 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, Sensei, and Artisan, as well as the company's heart design logo in use by itself or in combination with Hansen Medical, are trademarks or registered trademarks of Hansen Medical, Inc.
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SOURCE: Hansen Medical, Inc.