Stereotaxis Introduces First-of-its-Kind MAGiC Sweep™ a Robotically Navigated Mapping Catheter

Stereotaxis a leading company in surgical robotics for minimally invasive endovascular procedures, has submitted its MAGiC Sweep™ catheter for regulatory approval to the US Food and Drug Administration (FDA). The catheter is the first high-density electrophysiology (EP) mapping device designed for robotic navigation using Stereotaxis Robotic Magnetic Navigation systems.

High-density mapping has significantly advanced the field of electrophysiology by improving cardiac ablation procedures. This technique allows for more detailed, efficient, and precise identification of arrhythmia sources. 

Integrating high-density mapping with robotic technology offers several benefits, including faster and more accurate electroanatomical mapping using 20 electrodes, increased safety through an atraumatic catheter, and access to difficult-to-reach areas of the heart, and improved workflow during robotic procedures. 

Additionally, the robotic approach avoids distortions commonly caused by rigid catheters, leading to more anatomically accurate mapping results. The combination of Stereotaxis' robotic technology and the MAGiC Sweep catheter enables automated mapping with enhanced capabilities.

A 510(k) application has been submitted to the FDA for regulatory clearance, and an application for European CE Mark approval is expected to follow within the month. The MAGiC Sweep catheter has been designed and manufactured by Access Point Technologies, a wholly owned subsidiary of Stereotaxis based in Minnesota. 

This catheter is the first diagnostic device dedicated to Stereotaxis' robotic technology, complementing recent advancements in robotic ablation catheter development.

Stereotaxis continues to expand its robotic solutions, aiming to build a diverse portfolio of proprietary catheters. The acquisition of Access Point Technologies has played a crucial role in accelerating this progress. 

The MAGiC Sweep catheter marks another step forward for Stereotaxis in making heart procedures safer, more precise, and more efficient with robotic technology.