SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

June 06, 2012 16:01 ET

Hansen Medical to Exhibit Recently FDA Cleared Magellan™ Robotic System at National Meeting of Vascular Surgeons

Company to Commence Initial Commercial Launch in the United States Immediately

MOUNTAIN VIEW, CA--(Marketwire - Jun 6, 2012) - Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced it will exhibit its Magellan™ Robotic System at the 2012 Vascular Annual Meeting® of the Society for Vascular Surgery® from June 7-9 at Gaylord National Resort & Convention Center in National Harbor, MD. The Company recently announced receipt of 510(k) clearance from the U.S. Food and Drug Administration for the Magellan Robotic System, including the catheter and accessories, and will commence initial launch activities in the U.S. immediately.

The Magellan Robotic System is designed to simplify and enhance catheter navigation and therapeutic intervention through a variety of clinical cases in the peripheral vasculature. The Magellan Robotic System results in a new standard for peripheral vascular intervention with the potential to deliver revolutionary lesion access, precise distal tip control, solid catheter stability and consistent procedural efficiency.

"We are excited to showcase our Magellan Robotic System at this important annual meeting of leading vascular surgeons, as we believe this product has the potential to enhance the way physicians navigate the vasculature based on the clinical and pre-clinical work completed to date and feedback from a number of leading clinicians worldwide," said Bruce Barclay, President and CEO of Hansen Medical. "The robotic system and robotic 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 is designed to deliver predictable catheter navigation of peripheral vessels."

The Company will be exhibiting the Magellan Robotic System and conducting product demonstrations at Booth 418.

In addition, Jean Bismuth, M.D., of the DeBakey Heart & Vascular Center, Methodist Hospital in Houston, will be present at Hansen Medical's booth at 2:00 p.m. on Thursday, June 7th, to conduct product demonstrations and to share his experience using the Magellan Robotic System with other physicians in attendance.

"We are very pleased to have Dr. Bismuth, one of the pioneering clinicians in the use of intravascular robotics in endovascular procedures, spend time at our booth to conduct demonstrations of our Magellan Robotic System and to share his preclinical experience using our robotic catheter technology," Barclay added.

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 more than 8,000 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, 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 Company's Magellan™ Robotic System, NorthStar™ 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.

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 statements include statements about, the potential benefits of our Magellan Robotic System on the vascular procedures and the timing and results of commercializing our Magellan Robotic System. 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; 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; the effect of credit, financial and economic conditions on capital spending by our potential customers; our ability to manage expenses and obtain additional financing; and other risks more fully described in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012 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), and Sensei are registered trademarks, and Magellan is a trademark of Hansen Medical, Inc. in the United States and other countries.

Contact Information

  • Investor Contacts:
    Peter J. Mariani
    Chief Financial Officer
    Hansen Medical, Inc.
    650.404.5800

    FTI Consulting, Inc.
    Brian Ritchie
    212.850.5683
    Email Contact

    John Capodanno
    212.850.5705
    Email Contact