The Amigo™ Remote Catheter System: From Concept to Bedside.

Abstract

Radiation exposure is a serious concern during fluoroscopic procedures, including electrophysiology (EP) studies and radiofrequency catheter ablation of arrhythmias. Operators typically don lead aprons to protect themselves from radiation, but wearing lead can result in greater fatigue and orthopedic injury during long procedures. To address this problem, two robotic catheter systems (RCS) have previously been introduced on the market, the Niobe® (Stereotaxis Inc., St. Louis, MO, USA) and Sensei® X (Hansen Medical, Inc., Mountain View, CA, USA) systems. However, the widespread adoption of these systems has been limited by both cost and ease of use. In contrast, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) was developed to provide a simple, lower profile, and less expensive remote catheter manipulation solution. Approved by the United States Food and Drug Administration (FDA), this technology allows for operators to remotely manipulate electrophysiology (EP) catheters from outside the fluoroscopy field. Notably, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) first underwent an early study in dogs in 2008 to demonstrate its safety and efficacy in an animal model. After a clinical trial evaluating its safety and mapping capabilities in humans was completed in 2010, the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) underwent several scientific studies to examine its ability to assist in the mapping and ablation of various arrhythmias in comparison with the conventional manual approach. The Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) achieved mapping and ablation success rates that were similar to those achieved with manual catheter manipulation, and no complications due to its use were observed. It was approved by the FDA for use in diagnostic EP studies of the right atrium and ventricle in 2012, with this indication later expanded in 2014 to include radiofrequency ablations. The device is currently compatible with the Blazer™ (Boston Scientific, Natick, MA, USA) and EZ STEER™ (Biosense Webster, Inc., Diamond Bar, CA, USA) catheter handles. Here, we present a clinical report in which the Amigo™ RCS (Catheter Precision, Inc., Mount Olive, NJ, USA) was employed to map and ablate symptomatic supraventricular tachycardia. Dr. Cohen’s clinical experience with this robotic system is also reviewed.