Enrollment of Initial Cohort Completed in Hansen Medical's ARTISAN AF Clinical Trial

July 6, 2015—Hansen Medical, Inc. announced that it has completed enrollment in the initial evaluable cohort of the ARTISAN atrial fibrillation (AF) trial. ARTISAN is a prospective, single-arm, multicenter study being conducted in the United States and abroad. It is designed to evaluate the safety and effectiveness of the Hansen Medical’s Sensei robotic system and Artisan family of catheters for introducing and positioning specified commercially available radiofrequency ablation catheters in patients with symptomatic, drug-refractory, paroxysmal AF.

The Bayesian-designed study requires enrollment of an initial cohort of 125 patients, with subsequent enrollment permitted to support the endpoint analysis. The trial has two primary endpoints: safety (defined as the absence of early onset of all major adverse events) and efficacy (defined as freedom from atrial fibrillation through 1 year).

The Sensei robotic system, which combines three-dimensional catheter control and visualization, is powered by a robotically controlled arm that allows for catheter navigation, stability, and positioning within the patient’s heart atria. The Sensei robotic system, control catheters, 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 electroanatomic mapping and recording systems, using specified percutaneous mapping catheters.

The safety and effectiveness of this device for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established, advised the company.

In the company’s announcement, Joseph Gallinghouse, MD, of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas, commented, “This clinical trial is significant and sets a milestone for robotic technology in the treatment of patients with AF. The team here at St. David’s finds the Sensei robotic system reduces radiation exposure to the operator, while the Artisan catheter predictably navigates and provides a stable platform during AF ablation, a procedure which can sometimes last for hours.”