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Hansen Medical to Showcase Magellan(TM) Robotic System at Multidisciplinary European Endovascular Therapy Congress


December 1, 2011 - Mountain View, CA

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 it will showcase its Magellan™ Robotic System at the Multidisciplinary European Endovascular Therapy (MEET) Congress, from December 1-3, at the Crowne Plaza St. Peter's Hotel in Rome, Italy. The Company will be conducting product demonstrations and exhibiting the Magellan Robotic System at Booth 10.

Hansen Medical will also be exhibiting its NorthStar™ Robotic Catheter, designed to work with the Magellan Robotic System. The NorthStar Catheter is designed to simplify and enhance catheter navigation and therapeutic intervention in the peripheral vasculature. The Magellan Robotic System and NorthStar Robotic Catheter are CE marked and available for sale in Europe. They are 510(k) pending and not available for sale in the United States.

"We are excited to showcase our Magellan Robotic System and NorthStar Robotic Catheter at this foremost exhibition on endovascular therapy, and this is an important event in the initial commercial launch of our new system platform," said Bruce Barclay, president and CEO of Hansen Medical. "Based on the initial clinical and pre-clinical work and feedback from a number of leading clinicians worldwide, these products have the potential to optimize the way physicians navigate the vasculature. The CE marked system and catheter give physicians maximum flexibility and control through independent distal tip control of a catheter and a sheath as well as through robotic manipulation of a standard guidewire from a centralized, remote workstation. Moreover, this proprietary technology has the ability to provide physicians important clinical benefits by allowing precise and predictable catheter navigation of peripheral vessels."

The Magellan Robotic System and NorthStar Robotic Catheter are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

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 nearly 7,000 patients with cardiac arrhythmia, but includes a number of key changes specific to the peripheral vasculature. In particular, the Magellan Robotic System:

  • 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 with most 6F therapeutic devices on the market today.
  • Employs a catheter that is expected to be available in multiple lengths and has a low profile with significant flexibility to be compatible with most 6F treatment catheters currently used today.

Last year, the Company announced the completion of its First-in-Man study in Europe during which 20 endovascular procedures were performed with an earlier version of the Magellan Robotic System, demonstrating its potential to allow physicians to treat Peripheral Vascular Disease, while lessening radiation exposure.

In Europe, the Magellan Robotic System, including the NorthStar Robotic Catheter and related accessories, are CE marked. In the U.S., the Magellan Robotic System requires U.S. Food & Drug Administration (FDA) clearance, and a 510(k) application is currently pending. As such, the products are not commercially available in the U.S.

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 pending 510(k) 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 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," 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 forward looking statements include statements about the potential benefits of the Magellan Robotic System on the vascular procedures, and expected availability of catheters in multiple lengths. 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; 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), Sensei, and Artisan are registered trademarks, and Magellan and NorthStar are 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

MarketWire

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