CardioTek Announces FDA 510(k) Clearance for its EP‐Tracer, Electrophysiology Recording System with Built‐in Dual Channel Programmable Stimulator

CardioTek B.V. announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its EP‐Tracer System (FDA Reference Number K134044). The EP‐Tracer System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The EP‐Tracer System offers a space‐saving single-user interface for recording as well as stimulation. Stimulation can be redirected by software to any connected catheter pole of the recording system. In addition to the twelve-lead surface ECG and six auxiliary input channels, the EP‐Tracer offers 20, 52, or 84 bipolar intracardiac channels. The variety of system configurations allows stationary, mobile and even portable setups to address a physician tailored demand. CardioTek’s mission is to continuously design, manufacture and market reliable, flexible and durable EP recording systems with unmatched signal quality. Outside the United States the EP‐Tracer System is already well known, highly appreciated and proven in clinical use. Josep Brugada, MD, PhD, Spain: “The main advantage of the system is its compactness allowing single‐person use for both recording and stimulation.” Xu Chen, MD, Denmark: “The most advantages of the EP‐Tracer are the clear signals, beat‐to‐beat real-time view, small program to be used on various computers and the integrated stimulator.” Muhammad Munawar, MD, Indonesia: “The key features are automatic stimulation, clear recording, very good tracing, portable and sturdy. For the past seven years never gave a problem.” About CardioTek CardioTek team, headquartered in Maastricht‐Airport, has come a long way in more than 30 years, succeeding in creating excellent products for the best interest of cardiologists and their patients.