SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

May 05, 2011 16:01 ET

Hansen Medical Announces Shipment of 100th Sensei® Robotic Catheter System

Milestone Marks the Four Year Anniversary of System Clearance in U.S.

MOUNTAIN VIEW, CA--(Marketwire - May 5, 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 the Company has shipped its 100th Sensei® Robotic Catheter System, a major milestone for Hansen Medical, and only 4 years after the Company received FDA clearance in May, 2007. The 100th Sensei System was shipped to the University of Michigan.

"The Sensei X System is an exciting tool to implement in our new, state-of-the-art hospital for the care of pediatric and adult congenital patients, as well as in collaboration with our adult EP partners," said Dr. David J. Bradley, Director, Arrhythmia Service, C.S. Mott Children's Hospital, University of Michigan. "We are well aware of the benefits other centers have derived from the use of the System, and look forward to offering it to our patients."

"The shipment of our 100th Sensei System is a significant milestone for Hansen Medical, but more importantly it is a testament to the growing number of electrophysiologists and hospitals placing a high value on our flexible robotics technology," said Bruce Barclay, President and CEO of Hansen Medical. "Accomplishing this milestone in only four years after our initial FDA clearance is also indicative of the capabilities of our flexible catheter robotics system and the comfort level EPs have with it. This System was designed to allow EPs to perform complex procedures more quickly, with greater ease-of-use and with added radiation reduction benefits. We believe the System's continued acceptance in the marketplace demonstrates the success of its design.

"I would also like to congratulate the entire Hansen Medical team, since this milestone could only be achieved with their dedication and hard work," Barclay added.

The Sensei X Robotic Catheter System is the world's next-generation purely robotic flexible platform, combining advanced levels of 3D catheter control and 3D visualization for accuracy and stability during catheter-based electrophysiology procedures. By translating hand motions at the workstation to the control catheter inside a patient's heart, the Sensei X System's proprietary instinctive motion control technology empowers accurate and deliberate catheter placement.

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 and the Sensei X systems 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. In the US, the Vascular Robotic System is not available for sale pending clearance of the 510(k) submission, which is currently under review. In Europe, the Vascular Robotic System requires CE mark and is not available for sale, nor can it be marketed until the CE mark is received.

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 "believe," "potential," "expects," 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 acceptance of the Sensei system in the marketplace and the success of the System design. 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 Annual Report on Form 10-K filed with the SEC on March 16, 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), Lynx and Sensei are registered trademarks, and Artisan is a trademark, of Hansen Medical, Inc. in the United States and other countries.

Contact Information

  • Hansen Medical Contacts:
    Peter Osborne
    Interim CFO
    Hansen Medical
    650.404.5800

    Matt Clawson
    Allen & Caron Inc
    949.474.4300
    Email Contact