Press release

Publication of BIOTRONIK Home-CARE Clinical Study Results Confirms Potential New Approach for Earlier Detection of Cardiovascular Events

BIOTRONIK Home Monitoring® Uniquely Allows Potential Prediction of Cardiovascular-Related Hospitalization and Mortality

BERLIN, Germany, August 26, 2011—(BUSINESS WIRE)—BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices and pioneer of remote patient management solutions, announced today that results of the Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) clinical study were published in the European Journal of Heart Failure (doi:10.1093/eurjhf/hfr089).

Home-CARE was a prospective, nonrandomized, multicenter, international clinical trial enrolling 515 patients. The objective of this study was to develop an automated multiparameter algorithm that would use daily BIOTRONIK Home Monitoring® data to predict death and hospitalization for cardiovascular reasons dynamically. Seven physiological parameters (e.g., mean heart rate, patient activity, heart rate variability) were selected to better analyze the cardiovascular status of heart failure (HF) patients. The combination of all parameters resulted in 65.4% sensitivity in detecting cardiovascular hospitalizations and deaths with 99.5% specificity.

“We believe that combining several parameters into a single algorithm may improve the overall ability to risk-stratify patients with implanted cardiac devices. This unique, predictive approach was developed by BIOTRONIK to allow for earlier detection of cardiovascular events based on data collected for analysis by BIOTRONIK Home Monitoring®,” commented Professor Stefan Sack, MD, Coordinating Clinical Investigator, Schwabing Clinic, Munich, Germany. “The Home-CARE results also show that adding new physiological parameters increase the power of the cardiovascular predictor.”

BIOTRONIK Home Monitoring® uniquely offers reliable daily transmissions and real-time remote monitoring of device diagnostic data, which provides several exciting research and development opportunities. These opportunities include the ability to design and progressively optimize increasingly sophisticated multiparameter diagnostic algorithms, including new sensor technologies, and to prospectively evaluate their impact on patient outcomes, clinical administration and health economic burden.

“BIOTRONIK developed an algorithm able to potentially predict cardiovascular events in patients with HF. This achievement represents another example of our commitment to enhancing the quality of clinical evidence in this therapy area,” commented Marlou Janssen, Vice President of Global Marketing and Sales at BIOTRONIK. “Plus, this unique concept paves the way for future HF predictor applications and further expands the options of physicians for advanced patient management with BIOTRONIK Home Monitoring®.”

About BIOTRONIK SE & Co. KG
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 over 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.

Ref.: Sack et al. Eur. J. Heart Failure (2011) 13, 1019 Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostic for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study

 

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