AndhraNews.net
Home » Business News » 2011 » June » June 9, 2011

Hansen Medical to Exhibit Magellan(TM) Vascular Robotic System at National Meeting of Vascular Surgeons


June 9, 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 exhibit for the first time in the U.S. its newly branded Magellan™ Vascular Robotic System at the 2011 Vascular Annual Meeting® of the Society for Vascular Surgery® from June 15-18 at McCormick Place Lakeside Center in Chicago. The Company will be exhibiting the Magellan Robotic System at Booth 229.

Hansen Medical will also be exhibiting the newly branded NorthStar™ Robotic Catheter, designed to work with the Magellan Robotic System. The NorthStar Robotic Catheter is designed to simplify and enhance catheter navigation and therapeutic intervention through a variety of anatomies and lesions, including challenging anatomy, diffuse disease and chronic total occlusions, with minimal learning curve.

A highlight of the meeting includes a presentation by Jean Bismuth, M.D., of the DeBakey Heart & Vascular Center, Methodist Hospital in Houston, titled "The Role of Flexible Robotics in Overcoming Navigation Challenges in the Iliofemoral Arteries; A First-in-Man Study," from 6:03-6:15 p.m. on Wednesday, June 15. Dr. Bismuth's presentation is part of the Fifth Annual World Federation of Vascular Societies meeting held in conjunction with the 2011 Vascular Annual Meeting.

"We look forward to presenting the progress we have made with our Magellan Robotic System at this important annual meeting of leading vascular surgeons," said Bruce Barclay, president and CEO of Hansen Medical. "We believe our Magellan System, which features our proprietary flexible robotic technology with unique distal tip catheter control, has the potential to dramatically improve the way endovascular treatments are performed, while reducing procedure time, lessening radiation exposure and enabling new procedures.

"We are also pleased to have Dr. Bismuth, one of the pioneering clinicians in the use of flexible robotics in endovascular procedures, at the meeting to share his firsthand observations and the clinical results of our First-in-Man study, in which he played a prominent role," Barclay added. He noted that product demonstrations at the Company booth will allow physicians in attendance to experience the Magellan Robotic System and NorthStar Robotic Catheter throughout the meeting.

Hansen Medical's Magellan Robotic System is based upon the leading flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, and which has been used in more than 5,000 patients with cardiac arrhythmia, but with a number of key enhancements. In particular, the Magellan Robotic System:

  • Allows for complete, 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 with most 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 October, 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 improve the ability of physicians to safely, effectively and efficiently treat Peripheral Vascular Disease -- while exposing the patient, physician and hospital staff to less radiation.

In Europe, the Magellan Robotic System and NorthStar Robotic Catheter require a CE mark, are not available for sale, and cannot be marketed until the CE mark is received. In the U.S., the Magellan Robotic System requires U.S. Food & Drug Administration (FDA) clearance and is not commercially available. The Company filed for 510(k) clearance for the system and catheter with the FDA in April 2011.

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. The Magellan Vascular Robotic System requires regulatory filings and approval and is 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 Vascular Robotic System on the vascular procedures and the timing of 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.

Investor Contacts:
Peter Osborne
Interim CFO
Hansen Medical
650.404.5800

Matt Clawson
Allen & Caron Inc
949.474.4300
Email Contact

MarketWire

Comment on this story

Share