Feb 6 2015
Hansen Medical, Inc., a global leader in intravascular robotics, today announced FDA approval of an expanded protocol for the ARTISAN-AF IDE Study. The amended protocol now includes the use of the Thermocool® SmartTouch® Catheter (BioSense Webster, Diamond Bar, CA) and the EnSite Velocity Cardiac Mapping System (St. Jude Medical, St. Paul, MN).
These technologies are used in conjunction with the Sensei® Robotic System to complete ablation procedures for the treatment of paroxysmal atrial fibrillation per the IDE study protocol.
"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," said 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. "Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients."
Research has shown that the quality of ablation lesions is 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 Thermocool SmartTouch contact force sensing ablation catheter provides an objective measure of contact for optimal lesion creation. The stability and control of the Sensei system have the potential to improve contact between the catheter tip and heart wall1.
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 platform technology that enables electrophysiology procedures. It is important to keep pace with innovation in our field," said Cary Vance, Hansen Medical President and CEO. "By including innovative technologies in our clinical studies, we hope to offer even more benefit to physicians and patients."
The ARTISAN AF Trial is a prospective, single arm study of the Hansen Medical Sensei Robotic System for introducing and positioning certain irrigated radio frequency (RF) ablation catheters in patients with atrial fibrillation. The trial will enroll patients with symptomatic, drug-refractory paroxysmal atrial fibrillation and evaluate robotic technique for the ablation of atrial fibrillation. There are 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 one year.
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 alone2. 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.
Source: http://www.hansenmedical.com/