Posted in | Medical Robotics

Hansen Medical Elaborates on Evaluation of Catheter Contact Force Measurements Using RNS in Recent Publication

Hansen Medical, Inc., the global leader in intravascular robotics, today announced the latest publication in the Journal of Cardiac Electrophysiology: Analysis of catheter contact force during atrial fibrillation ablation, using the robotic navigation system: results from a randomized study.

The purpose of this study, led by Dr. Antonio Dello Russo and Dr. Claudio Tondo of the Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino in Milan, Italy, was to evaluate catheter contact force (CF) measurements both with and without the use of Sensei® X robotic navigation system (RNS) during pulmonary vein isolation (PVI) procedures. The study evaluated eighty patients with symptomatic atrial fibrillation (AF). Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter.

Atrial fibrillation ablation was performed successfully in all patients without complications, CF and the 1-year freedom from AF recurrence was higher in the RNS group while this same group was observed to have a significant reduction in fluoroscopy time (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05).

Dr. Joe Gallinghouse, M.D., Cardiac Electrophysiologist at St. David's Medical Center in Austin, Texas and Principal Investigator of the ARTISAN AF IDE Study previously stated, "There is a substantial amount of innovation in the treatment of atrial fibrillation for catheter ablation, including distal tip contact force sensing catheters like SmartTouch. Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients." The company recently completed enrollment in the ARTISAN AF IDE Study designed to support the expansion of the company's current labeling in the U.S. beyond mapping.

The research from Cardiologico Monzino in Milan, Italy continues to support the quality of the ablation lesions based on a combination of the contact between the catheter tip and heart wall, the power of the applied radiofrequency energy, and the amount of time the energy is applied. The stability and control of the Sensei system improves the contact between the catheter tip and heart wall. The EnSite Velocity Mapping System facilitates 3D navigation of catheters in the heart atria. Sensei's CoHesion feature offers physicians excellent catheter control by integrating the EnSite Velocity 3D map into the navigation function of Sensei's physician workstation.

"The Sensei Robotic System is a key technology which enables electrophysiology procedures. The results from the team at Cardiologico Monzino in Milan prove the need for this critical technology," said Cary Vance, Hansen Medical President and CEO. "By continuing to innovate technologies, more and more physicians have the ability to achieve these types of results, ultimately providing the patients with perfected outcomes."

Cardiac arrhythmias are abnormal electrical signals in the heart. Atrial fibrillation is the most common form of cardiac arrhythmia, affecting nearly 3 million people in the United States alone. In radiofrequency catheter ablation, a catheter is inserted into left atrium and radiofrequency energy is delivered to the heart tissue to create scars, which are intended to block erratic electrical impulses so the left atrium can beat normally.


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