SOURCE: Hansen Medical, Inc.

Hansen Medical, Inc.

January 25, 2012 09:00 ET

British Surgeons Pioneer Endovascular Surgery With Hansen Medical's Magellan™ Robotic System

St. Mary's Hospital Performed First Ever Fenestrated Endograft Procedure Using Robotic Technology

MOUNTAIN VIEW, CA--(Marketwire - Jan 25, 2012) - 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 for the first time ever, surgeons at St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust, in London, UK, used the Company's Magellan™ Robotic System to treat a patient with a complex abdominal aortic aneurysm.

"This new technology means a broader group of patients who have complex disease might now be operated on," said Professor Nick Cheshire, consultant vascular surgeon and head of circulation and renal sciences at Imperial College Healthcare. "Here at St. Mary's we've pioneered the use of robotics in vascular surgery and have worked with Hansen Medical to develop this robotic system. We're committed to building on this technology to develop new procedures, and to bring our patients the latest and best treatments first."

In this specific procedure the physicians used the Magellan Robotic System to deliver a stent through the endograft and into the patient's renal artery. "The real trick here is to drive into the blood vessel though the stent [endograft], and then out through the specially formed window into the kidney vessel," stated Prof. Cheshire in an interview with the British Broadcasting Company (BBC). "On the right side using conventional [manual] technique, it took us about... an hour and twenty minutes. On the left side of this patient, when we used the robot, it took us about twenty minutes."

"Hansen Medical's new Magellan robotic system is the first such system specifically designed for peripheral endovascular interventions," said Bruce Barclay, president and CEO of Hansen Medical. "It is designed to be flexible and versatile, allowing physicians to use it for complex catheter procedures."

The new robotic system is controlled from a workstation outside of the operating room. It displays the patient's blood vessels on a screen and allows the clinician to navigate through them with a flexible robotic catheter. The clinician can steer the catheter and position its moveable tip and joints to access the patient's peripheral anatomy.

Consultant interventional radiologist Dr. Mo Hamady, who operated the robot, said, "This technology means you have control during complex procedures such as this. Whereas surgeons would normally feed the catheter into the patient's body by hand, the robot gives you precision so there is the potential for less risk of damage to the wall of the patient's blood vessels and the procedure can be completed fast."

For the patient, having endovascular robotic surgery involves a small incision or 'cut' in the groin, with minimal blood loss. Use of the robotic catheter has the potential to make the procedure more predictable, to require less time, and to improve technical accuracy and control. Patients who undergo an endovascular procedure typically have a shorter hospital stay with an average recovery time of five days compared with ten days or longer for open surgery.

The Company will showcase its Magellan Robotic System at the Leipzig Interventional Course (LINC), from January 25-28, at the Trade Fair Leipzig, Hall 4, in Leipzig, Germany. On Friday January 28, the company will host a hands-on course on the Magellan Robotic System. This course will be directed by Professor Cheshire, M.D., of St. Mary's Hospital.

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 7,000 patients with cardiac arrhythmia, but includes a number of key enhancements. 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 better access hard to reach peripheral anatomy.
  • Preserves the open architecture featured in the Sensei System to allow for the subsequent use of 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.

In 2010, the Company announced the completion of its First-in-Man study in Europe during which 20 endovascular procedures were successfully performed with an earlier version of the Magellan Robotic System, demonstrating its potential to allow physicians to effectively 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 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 conformity assessment and CE marking and are commercially available in the European Union.

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 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 timing of FDA clearance of our Magellan™ Robotic System in the US, the potential benefits of our Magellan Robotic System on the vascular procedures and the timing 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 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), and Sensei are registered trademarks 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.
    Sharrifah Al-Salem, CFA
    415.293.4414
    Email Contact

    John Capodanno
    212.850.5705
    Email Contact