April 03, 2012 06:48 ET

RECORD Study Proves Efficacy and Safety of BIOTRONIK Closed Loop Stimulation (CLS) Pacemaker Therapy

CLS Heart Rate Adaption and Medical Benefit Is Excellent in Approximately 80% of Patients

BERLIN, GERMANY--(Marketwire - Apr 3, 2012) - Breakthrough results from more than 700 patients studied in the largest-ever clinical investigation of BIOTRONIK CLS pacemakers have just been published in Europace: "Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS Routine Documentation Registry (RECORD)" by Michaela Lindovská, MD, et al.

Under routine clinical conditions, clinical investigators from 57 study centers graded the technical performance and medical benefit of BIOTRONIK CLS as "excellent" in nearly 80% of the evaluated patients, a clear indication of improved confidence and satisfaction. A full 706 patients at evaluation sites in Germany, Czech Republic, Austria and Hong Kong were studied. Patients treated with a single- or dual-chamber BIOTRONIK pacemaker were eligible for enrolment if the CLS mode was activated. Reprogramming of CLS-related parameters was rarely undertaken: More than 90% of pacemakers operated with default settings in the long term.

CLS Technology -- unique to BIOTRONIK pacemakers -- is the only sensor system in the world that can trigger changes in heart rate in order to optimize cardiovascular flow not only based on physical activity, but also based on acute mental excitement or stress.

The RECORD investigation of CLS pacemakers is the largest to date and demonstrates excellent performance in all pacing sites within the right ventricle (apical, septal, outflow tract), and even in advanced heart failure with no difference to patients without heart failure.

"RECORD is an extraordinary and extremely important study. The statistics it provides dramatically advances our understanding of the effectiveness of CLS," said Michaela Lindovská, MD, Cardiology Bulovka, Prague, Czech Republic. "To have this information in hand provides a greater level of confidence not only for the medical community, but also for the thousands of patients around the world who depend on this device in life-saving procedures."

About Closed Loop Stimulation (CLS)
Closed Loop Stimulation is a unique physiologic technology of rate-adaptive pacing. It is the only sensor system in the world that can trigger changes in heart rate to optimize cardiovascular flow during mental excitement or stress. CLS integrates into the natural cardiovascular control system and determines the appropriate heart rate based on intracardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS is available for selected BIOTRONIK pacemakers, including ones featuring the original BIOTRONIK Home Monitoring® service.

As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success -- and deliver confidence and peace of mind to physicians and their patients worldwide.

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