SAN FRANCISCO, May 7, 2014 /PRNewswire/ -- Cardiotek B.V., a subsidiary of Schwarzer, a privately held medical device company focused on electrophysiologic (EP) and hemodynamic measurement systems, today announced it will commence commercialization of its EP-Tracer System following the 2014 Heart & Rhythm Society (HRS) Meeting in San Francisco, CA.
The EP-Tracer System is a recording device with a built-in dual-channel programmable stimulator that is currently used worldwide by key opinion leaders in the EP community. Targeted U.S. commercialization of the FDA approved EP-Tracer System will begin later this month as part of a comprehensive U.S. go-to-market strategy.
The EP-Tracer System provides excellent signal quality controlled by a compact, single-user unit. The easy-to-use 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.
"Throughout the majority of my career and for thousands of ablations, I have used the EP-Tracer System as my primary EP recording system. The system offers superior signal quality in a compact, single-user system," commented Dr. Josep Brugada M.D. Ph.D., Electrophysiologist and Medical Director at the University of Hospital Clinic Barcelona in Spain. "The EP-Tracer System provides a simplified approach to therapeutic procedures."
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. Electrophysiology is a $2.5 billion global market that is growing at nearly 10% annually.
"The EP-Tracer System is one of the preferred recording devices in Europe with an installed base of approximately 1,000 systems," commented Frank-P. Klein, President and Chief Commercial Officer of Schwarzer. "We are excited to bring the EP-Tracer System to the U.S. and believe it will transform the market by offering physicians a higher quality and more portable system for EP procedures."
The EP-Tracer System received FDA 510(k) clearance in March 2014 and will be on display at booth #711 at the HRS meeting, May 7th-10th.
About Schwarzer Cardiotek
Schwarzer, the parent company of Cardiotek B.V., is a privately held medical device company focused on electrophysiologic (EP) and hemodynamic measurement and recording systems. The company has a 25-year history in developing and manufacturing solutions for electrophysiology recording. Cardiotek utilizes a comprehensive approach of creative thinking and collaboration with leading physicians and researchers around the world to continuously enhance its products and stay on the forefront of technological innovation. For more information please visit http://www.cardiotek.com.
About EP Tracer
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 compact, easy-to-use recording system provides superior signal strength with a built-in dual channel programmable stimulator for electrophysiology (EP) studies. The EP-Tracer System is commercially available in Europe with approximately 1,000 systems installed worldwide.
SOURCE Cardiotek B.V.