SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

July 25, 2011 09:00 ET

Hansen Medical Receives CE Mark for Its Magellan™ Robotic System for Peripheral Vascular Interventions

Company to Commence Initial Launch in Europe

MOUNTAIN VIEW, CA--(Marketwire - Jul 25, 2011) - 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 that it has completed the European Union conformity assessment procedure and affixed a Conformité Européenne (CE) Mark on its Magellan™ Robotic System.

The Magellan Robotic System is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. This System was designed to assist physicians to safely, effectively and efficiently treat a variety of peripheral vascular diseases. While the CE Mark enables Hansen Medical to commence full commercial launch of the Magellan Robotic System in the European Union, the Company will commence commercialization at selected centers initially, with a full launch expected in the first half of 2012.

"The Magellan Robotic System is a remarkable new tool that may offer important clinical benefits for physicians performing peripheral interventions," said Professor Nicholas Cheshire, M.D. of St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust in London. Professor Cheshire is a pioneer in the use of flexible robotics in vascular interventions.

"The Magellan System enables physicians with proprietary 3D robotic control of the catheter tips to navigate efficiently through a variety of anatomies and lesions while seated comfortably and away from radiation. As a result of our in vitro and in vivo animal studies, I believe using this platform has the potential to increase efficiencies in the interventional lab by shortening procedure times and allowing more predictable interventions. Finally, this System may facilitate new patient treatment options by enabling robotic endovascular interventions," Professor Cheshire added.

Hansen Medical President and CEO Bruce J Barclay called CE marking the System and the Company's entrance into the European peripheral vascular market "a fundamental building block to the future growth of our business." Hansen Medical's new London Education Centre and European headquarters will serve as the hub for its commercial, training and physician support activities in association with the initial phase of the European launch of the Magellan Robotic System, including placement, training and clinical education of select users in multiple countries, Barclay noted.

"A CE Mark of the System demonstrates our belief in the safety and technical efficacy of our Magellan Robotic System," Barclay said. "In addition, today's announcement is a testament to the talented development teams at Hansen Medical that worked tirelessly to achieve our CE Mark, and they are all to be congratulated. For Hansen Medical, CE mark allows us to initiate a selective commercial launch of our Magellan Robotic System in the large and rapidly expanding European Union peripheral vascular market. Once key initial sites are successfully up and running, we will commence full launch activities. We have received positive feedback from many physicians that our Magellan Robotic System and its multiple features and benefits, including the distal tip catheter control and remote operating environment, may enable their peripheral procedures."

The Magellan System is designed for use with the NorthStar™ Robotic Catheter and related accessories, and the Company anticipates that these CE Marks will follow soon. In the U.S., the Magellan Robotic System requires U.S. Food & Drug Administration (FDA) clearance and is not commercially available. The Company submitted a 510(k) pre-market notification application for the Magellan Robotic System, the NorthStar Robotic Catheter and accessories with the FDA earlier this year.

The global vascular market is large and expanding rapidly, driven by an aging population, the prevalence of diabetes and obesity and an increase in disease awareness. Of the more than 2 million vascular procedures done each year, approximately one-third to one-half of them are potentially addressable by the Magellan Robotic System.

About Hansen Medical's Magellan™ Robotic System
Hansen Medical's Magellan Robotic System is based upon the Company's leading flexible robotic platform, which has been used in more than 6,000 cardiac arrhythmia procedures. The System has been optimized with a number of key enhancements for peripheral vascular interventions. In particular, the Magellan Robotic System:

  • Allows for complete, individual 3D robotic control of the distal tips of both the outer sheath and inner leader catheter, as well as robotic manipulation of standard guidewires.
  • Features robotic sheath stabilization for precise therapy delivery.
  • Enables catheter and guidewire manipulation while comfortably seated remotely from the radiation source.
  • Employs a proprietary robotically steerable catheter with a low profile and significant flexibility to be compatible with most 6F treatment catheters currently used today.
  • Is designed to fit in existing hybrid operating rooms and interventional labs without requiring costly remodeling.
  • May cause less damage to arteries than conventional technique, as shown in in-vivo animal studies.
  • Has the potential to be faster and more predictable than conventional manual technique.
  • Has the potential to facilitate new patient treatment options by enabling robotic endovascular interventions.

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® system and its Sensei X Robotic Catheter System 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 and Sensei X systems for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including atrial fibrillation (AF), have not been established during EP procedures, such as guiding catheters in the treatment of AF. In the European Union, the Sensei X system and the Artisan™ Control Catheter are CE Marked for use during EP procedures, such as guiding catheters in the treatment of AF, and the Lynx® Robotic Ablation Catheter is CE Marked for the treatment of AF. The Magellan Robotic System has undergone conformity assessment and CE marking and is commercially available in the European Union. The NorthStar Catheter and related accessories are not yet CE marked. In the U.S. the Magellan Robotic System, catheter and accessories are the subject of a pending filing with the FDA but 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. Hansen Medical intends 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 the potential benefits of our Magellan Robotic System on the vascular procedures and the timing of and potential success in 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 May 10, 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, and Artisan, Lynx, Magellan and NorthStar are trademarks, of Hansen Medical, Inc. in the United States and other countries.

Contact Information

  • Investor Contacts:
    Peter Mariani
    CFO
    Hansen Medical
    650.404.5800

    Matt Clawson
    Allen & Caron Inc
    949.474.4300
    Email Contact