Cardiotek U.S. Commercialization of EP-Tracer System


May 7, 2014

The EP-Tracer system is a recording device by Cardiotek B.V., a subsidiary of Schwarzer, a privately held medical device company focused on electrophysiologic (EP) and hemodynamic measurement systems, with a built-in dual-channel programmable stimulator that is currently used worldwide. It was commercialized in the United States in May 2014.

The EP-Tracer system is an EP measurement system used to acquire, filter, digitize, amplify, display and record signals obtained during electrophysiological studies and related procedures. The compact, easy-to-use recording system provides superior signal strength with a built-in dual channel programmable stimulator for EP studies. The EP-Tracer system is commercially available in Europe with approximately 1,000 systems installed worldwide.

The EP-Tracer system provides signal quality controlled by a compact, single-user unit. The integrated programmable stimulator, which allows stimulation on all intracardiac inputs, has three model options and offers up to 102 intracardiac channels. System customization allows for portable, mobile and stationary configurations to optimally suit the customer needs and improve system utilization across EP labs.

EP studies are used to diagnose and treat a variety of conditions in which the heart beats abnormally, including atrial fibrillation (AF). During EP testing, the recording system acquires, measures and records intracardiac signals as well as stimulates the heart to assist the physician in the diagnosis and treatment.

The EP-Tracer system received 510(k) clearance in March 2014.

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