Hansen Medical's Magellan™ Robotic System to Be Presented at International Symposium

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 its Magellan™ Robotic System will be presented at the upcoming 38th annual VEITHsymposium™ November 16-20 at the Hilton New York in New York City.

"This five-day annual symposium is one of the year's most important gatherings of vascular surgeons and interventionalists from around the world. Based on the initial clinical and pre-clinical work and feedback from a number of leading clinicians worldwide, I believe our robotic system has the potential to revolutionize the way physicians navigate the vasculature," said Bruce Barclay, president and CEO of Hansen Medical. "Already approved in Europe, the Magellan Robotic System gives physicians more flexibility and control than ever before 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 may provide physicians important clinical benefits by allowing precise and predictable catheter navigation of peripheral vessels."

The scientific program of the VEITHsymposium features the following presentations on Hansen Medical's flexible robotics technology:

"Advantages of a Robotic Guidance System for Catheter Steerage in the Performance of Fenestrated and Branched Endografting (The Hansen System)" by Professor Nick Cheshire, M.D., of St. Mary's Hospital, part of the Imperial College Healthcare NHS Trust, in London, England from 6:58 a.m.-7:03 a.m. on Friday, November 18, 2011.

"Advantages of the Hansen Remotely Steerable Catheter and Sheath System in Endovascular Procedures" by Professor Alan Lumsden M.D. of the DeBakey Heart & Vascular Center in Houston from 7:15 a.m.-7:20 a.m. on Friday, November 18, 2011.

In addition, Hansen Medical will be exhibiting the Magellan Robotic System and the NorthStar™ Robotic Catheter and be conducting product demonstrations at booth #207.

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 nearly 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 with 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.

Last year, 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.

Source: 
Hansen Medical

     
 

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