Hansen Medical, Inc. has received FDA 510(k) clearance to market the CoHesion (TM) 3D Visualization Module for use in complex electrophysiology (EP) mapping procedures.

Hansen Medical, Inc. (NASDAQ: HNSN), a developer of robotic technology for accurate 3D control of catheter movement during cardiac procedures, has received US Food and Drug Administration (FDA) 510(k) clearance to market the CoHesion (TM) 3D Visualization Module for use in complex electrophysiology (EP) mapping procedures. This integrated EP solution offers a software interface between the Hansen Medical Sensei(TM) Robotic Catheter system and the EnSite (TM) System advanced mapping software from St. Jude Medical, Inc. Hansen Medical's platform solution offers physicians the ability to instinctively navigate a catheter during the diagnostic phase of a complex cardiac arrhythmia procedure. The new CoHesion module imports the EnSite System's 3D cardiac chamber model with anatomic labeling into the Sensei system's main navigation window, allowing physicians to see the location of Hansen Medical's Artisan(TM) Control Catheters within the heart in 3D.

Earlier this year, the CoHesion module was released in the European Union and there are currently eight European Sensei systems configured with the new module. One location is the University Heart Center at the University Hospital Hamburg-Eppendorf in Germany, where Professor Stephan Willems*, director of Clinical Electrophysiology and his staff are using CoHesion to remotely manipulate catheters during EP procedures.

We are performing procedures with great confidence utilizing CoHesion and we find it easy to move catheters within the 3D cardiac space, said Professor Stephan Willems. We are also seeing a large reduction in the amount of time we use fluoroscopy, which is a benefit to both the patient and physician. For example, in some cases we are able to complete the procedure with less than ten minutes of fluoroscopy time.

The EnSite System offers state of the art technology for localization and visualization of EP catheters in 3D, and the Sensei system offers 3D remote manipulation of catheters with instinctive control. Previously, two dimensional technologies, such as fluoroscopy or ultrasound were used to assist physicians with guiding catheters inside the heart. Combining the Sensei and EnSite System technologies is intended to provide physicians with 3D visualization that is expected to optimize control over placement of the catheter in specific locations.

This integrated platform solution is another step in our ongoing strategy to expand our offering to electrophysiologists and ensure that Hansen Medical is at the forefront of finding effective clinical solutions to help physicians, said Frederic Moll, MD, co-founder and CEO of Hansen Medical. The CoHesion Module expands our product offerings to provide physicians with what we believe to be a comprehensive and easy to-to-use remote navigation system for complex arrhythmia procedures.

St. Jude Medical's EnSite System is an advanced technology for mapping the electrical activity of the heart, and for localizing and visualizing electrophysiology catheters in real-time. The EnSite System creates 3D graphical displays of cardiac anatomy and arrhythmias, and enables catheter navigation without the use of fluoroscopy.

The Sensei system uses computer-based catheter technology to provide stable and predictable control of catheter movement. This innovative technology is designed to provide fine guide catheter control in 3D to enable physicians the ability to access hard-to-reach anatomy, and to maintain stability during interventional procedures. The physician workstation is adaptable to existing EP procedure rooms and can be placed away from the field of direct radiation. The disposable Artisan(TM) Control Catheter is comprised of inner and outer steerable guide catheters that accommodate indicated percutaneous catheters.

Hansen Medical technology was recognized in March 2008 by Frost & Sullivan, and presented with the consulting company's 2008 Product Innovation Award in the field of US Image-Guided and Robotic-Assisted Surgery Devices.