Pre-Clinical Study and Initial Clinical Experience Highlight Potential Benefits of Hansen Medical's Robotic Technology in Treating Carotid Arteries

Study Results Published in Journal of Cardiovascular Surgery

Marketwired

MOUNTAIN VIEW, CA--(Marketwired - Apr 30, 2013) -  Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced the results from a recently published pre-clinical study describing potential benefits of Hansen Medical's robotic technology for the treatment of carotid arteries. The study results appeared in the Journal of Cardiovascular Surgery, December 2012.

The study was conducted by a team of clinicians under the guidance of Professor Nick Cheshire, MD of St Mary's Hospital and Head of Circulation Sciences at Imperial College Healthcare. The purpose of the study was to investigate whether the use of the robotic system could reduce the embolic risk associated with carotid artery stenting. The study was performed using a predecessor robot to Hansen Medical's Magellan™ Robotic System in a pulsatile in vitro model of the aortic arch and carotid arteries.

"A common concern of endovascular intervention in the aortic arch and carotids is the risk of embolization and resulting neurologic deficit, including stroke, due to the presence of vessel tortuosity, angulation, arterial plaque and calcification, and poor patient selection," said Professor Cheshire. "A high level of operator skill and experience is important in reducing the risk of embolization, and ensuring a successful outcome. However, few operators today possess the skill necessary to consistently generate positive clinical results in these complex cases."

"Our studies have demonstrated several potential benefits of using Hansen's robotic catheter technology for complex endovascular procedures, especially those procedures involving the aortic arch and the great vessels including the carotid arteries," said Dr. Celia Riga, MD Vascular Surgeon and NIHR Clinical Lecturer, Imperial College London. "The preclinical data suggests that endovascular robotic technology may facilitate endovascular intervention through improved catheter maneuverability, stability and control, even for less experienced interventionalists. This technology also has the potential to reduce manual skill required in the presence of challenging anatomy and may thereby shorten the learning curve we have historically seen in carotid artery stenting. Additional potential benefits may include reduced procedure times through efficient cannulation and lesion crossing, reduced instrumentation and vessel wall contact, and overall stability for the controlled delivery of therapeutic devices."

Beyond this pre-clinical study, the Company reported that other centers have reported using the Magellan System to successfully access and treat carotid arteries in patients. One of these centers is the Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami), with the cases being performed by or under the direction of Dr. Barry Katzen, founder and Medical Director of the Institute.

"Carotid artery intervention is one of the most challenging endovascular procedures being performed today, given the anatomic complexity and high clinical risk," said Dr. Katzen. "At the Baptist Cardiac & Vascular Institute, we have successfully performed several carotid procedures with the Magellan System. The ability to navigate tortuous vessels and place a sheath in the carotid artery without catheter changes, and with minimal vessel wall touches, offers great potential advantages."

"We are encouraged by the breadth of clinical anatomy in which the Magellan System is currently being used to treat patients with peripheral vascular disease," said Bruce Barclay, president and CEO of Hansen Medical. "We believe that, as clinical experience with the Magellan System grows, it will demonstrate that our technology provides benefits within a broad variety of endovascular procedures and for even the most skilled manual operators."

About Carotid Artery Disease
Carotid artery disease is a condition in which the carotid arteries become narrowed or blocked, and the resulting condition is called carotid stenosis. A common cause of stroke is a blockage in the carotid arteries. Stroke, or cerebrovascular accident, is most frequently caused by a sudden stoppage of blood flow to a portion of the brain. Every year in the United States an estimated 750,000 people become victims of stroke. The carotid arteries carry blood to the brain; like the blood vessels that supply blood to the heart, these arteries can become narrowed or blocked. The blockages are deposits of cholesterol, or atherosclerosis, that narrow the blood flow channel in the carotid arteries. If these cholesterol deposits or blockages break or rupture, small blood clots and cholesterol fragments break off from the plaque, enter the blood flow to the brain, and can get caught in a smaller blood vessel in the brain, thus stopping blood flow to that area of the brain. The larger the cholesterol plaque and more severe the blockage of the carotid artery, the higher the risk of stroke.

About the Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, which has been used in over 10,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:

  • Provides solid catheter stability for placement of therapeutic devices.
  • Is designed to enable predictable procedure times and increased case throughput.
  • Allows for independent, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guidewires.
  • Is designed to allow for sufficient extension inside the body to access hard to reach peripheral anatomy.
  • Preserves the open architecture featured in the Sensei System to allow for the subsequent use of many 6F therapeutic devices on the market today.
  • Is designed to potentially reduce physician radiation exposure and fatigue by employing a remote physician workstation.

About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company's Magellan™ Robotic System, Magellan 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 both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company's Sensei® X Robotic Catheter System and Artisan Control Catheter are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S. 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 EP procedures. 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 AF, have not been established. Additional information can be found at www.hansenmedical.com.

Forward-Looking Statements
This press release contains forward-looking statements regarding, among other things, statements relating to goals, plans, 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 benefits of the Magellan™ Robotic System in treating disease in the carotid arteries and other parts of the peripheral vasculature. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: adverse events or unfavorable clinical results, including patient injury or death; insufficient or unfavorable clinical data; potential safety and regulatory issues that could slow or suspend our sales; the effect of credit, financial and economic conditions on capital spending by our potential customers; the uncertain timelines for the sales cycle for newly introduced products; 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; our ability to manage expenses and cash flow, and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-K for the year ended December 31, 2012 filed with the SEC on March 18, 2013 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), Sensei and Lynx are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

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