HNSN Hansen Medical, Inc. (MM)

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced the initiation of a clinical trial designed to evaluate its flexible catheter Sensei® X Robotic System in patients with ventricular tachycardia (VT).

The Sensei® X Robotic System features a flexible catheter with remotely steerable distal tips designed to simplify and enhance catheter navigation and therapeutic intervention. The Study, titled Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia (ERASE-VT), is designed to enroll 200 patients with implantable defibrillators (ICDs) at up to eight sites in Europe. The primary endpoint of the study is to reduce or eliminate episodes of VT, and the secondary endpoints are to evaluate the effects of robotic ablation on patient hospital length of stay, mortality, and quality of life. The patient follow-up is two years. The study is being sponsored by Imperial College of Science Technology and Medicine out of the Cardiology Department at St. Mary's Hospital.

Dr. Prapa Kanagaratnam, electrophysiologist and the study's principal investigator, St. Mary's Hospital, London, commented, "Our unit has already demonstrated the ability of the flexible catheter Sensei® X Robotic System to improve radiofrequency lesion quality through greater catheter stability and precision compared to the conventional manual approach. As the mechanism of ischaemic VT is well understood, we believe that this arrhythmia is particularly suited to translating these advantages to clinical improvements for patients. We have already had a number of cases that were successful with the Sensei® X Robotic System that had previously failed with a conventional ablation approach. Therefore, we are very excited to work with Hansen Medical and the leading robotic centers in Europe to evaluate their products in a clinical trial testing the novel clinical indication of robotic ablation after the first episode of VT in patients with an ICD versus conventional medical therapy." Dr. Kanagaratnam enrolled the first patient in the study.

"We are pleased to provide financial support of this physician-driven study as further evidence of our commitment to developing innovative products that provide clinical improvements for our electrophysiology customers and their patients," said Bruce Barclay, Hansen Medical's President and CEO. "Based on the early clinical feedback, we believe that flexible robotics from Hansen Medical have the potential to provide benefits not available with conventional manual catheter ablation, and we look forward to generating the data necessary to develop this new application for our products."

About Ventricular Tachycardia Ventricular Tachycardia (VT) is an abnormal rapid heartbeat, which can be life-threatening because it may lead to ventricular fibrillation, asystole, and sudden cardiac death. Patients at risk for VT often receive an implantable defibrillator (ICD) that can prevent death, but also can generate painful and debilitating shocks. VT is one of the most challenging arrhythmias facing electrophysiologists due to complex anatomy, the sensitive nature of ventricular tissue, and potentially lethal outcomes. It is estimated that sudden cardiac death, a complication of VT and ischemic heart disease, claims about 250,000 lives in the U.S. each year alone. It is estimated that approximately 25,000 VT ablations will be performed worldwide in 2011, with an annual market of over $100 million.

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 Sensei X System and Artisan Control Catheter are not approved for the use in the treatment of VT. The Company's Magellan™ Robotic System, which is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, has undergone conformity assessment and CE marking and is commercially available in the European Union. The NorthStar™ Robotic Catheter and related accessories designed for use with the Magellan Robotic System are also CE marked. 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.

Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words "plan," "potential," "believes," and similar words. Examples of such statements include statements about the potential benefits of our Sensei system in the treatment of patients with ventricular tachycardia, and statements about the potential benefits of our vascular robotic system on the vascular procedures and the timing of commercializing our vascular robotic system. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, potential safety and regulatory issues that could delay, suspend or terminate future clinical studies or regulatory approvals, challenges in designing, engineering and manufacturing systems to function as intended, uncertain timelines, costs and results of clinical trials, and the scope and validity of intellectual property rights applicable to products being developed. 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 8, 2011. 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.

Investor Contacts: Peter J. Mariani Chief Financial Officer Hansen Medical, Inc. 650.404.5800 FTI Consulting, Inc. Sharrifah Al-Salem, CFA 415.293.4414 Email Contact John Capodanno 212.850.5705 Email Contact