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Hansen Introduces Sensei X2 Robotic System to the US and European Markets

Hansen Medical, Inc., a global leader in intravascular robotics, today announced the Sensei X2 Robotic System is commercially available in the U.S. and European Union. Sensei X2 is a technological leap forward; featuring faster processing speeds, enhanced image integration, and a lower profile design. Launch of Sensei X2 is a key milestone as Hansen continues to deliver on its pipeline of innovative robotic platforms for electrophysiology procedures.

"Sensei X2 incorporates insights from years of technical and clinical experience with the Sensei Robotic System in electrophysiology procedures," said Will Sutton, Hansen Medical's Chief Operating Officer. "With the growing body of evidence in over 26 clinical studies, we believe Sensei X2 will continue to aid electrophysiologists in improving patient outcomes."

"The introduction of the Sensei X2 Robotic System to the US and European markets demonstrates Hansen's commitment to electrophysiology," said Cary Vance, Hansen Medical President and Chief Executive Officer. "The advancements with Sensei X2 represent Hansen's ability to continually deliver on a robust, new product pipeline."

The Sensei X2 is the third generation Sensei system. The technology has been used in over 14,000 procedures. Sensei has also been the subject of 26 clinical studies, with data collected from more than 2,700 patients. Evidence confirms low complication rates, high average contact force, catheter stability, and reduced fluoroscopy time when compared with manual procedures.

The Sensei X2 Robotic System is an advanced technology used during electrophysiology procedures to remotely navigate a robotic catheter in the heart atria. Sensei technology offers catheter stability, accuracy, and access to hard-to-reach areas of the atria. Sensei's remote workstation integrates multiple imaging sources used by the physician during electrophysiology procedures. Use of Sensei has been demonstrated to reduce fluoroscopy radiation exposure during left atrial electrophysiology procedures.

1. Kaplan, A. Three-Year Experience with the Robotic Catheter System. EP Lab Digest. May 2013.

About Sensei® Robotic Catheter System

Sensei Robotic System combines advanced levels of 3D catheter control and 3D visualization to remotely navigate a catheter for electrophysiology procedures. Sensei's robotically controlled arm allows for catheter navigation, stability and positioning within the patient's heart atria. This unique, state of the art technology has been used in over 14,000 patients and 26 studies with over 2,700 patients studied.

Indications for Use in the United States: The Hansen Medical Sensei® Robotic System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established in the United States.

Indications for Use in the European Union: The Sensei® Robotic System, control catheters and accessories are intended to facilitate manipulation, precise positioning and control of percutaneous catheters within the atria of the heart.



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