BIOTRONIK completes patient enrollment in IN-TIME clinical trial to treat HF

BIOTRONIK SE & Co. KGMar 30 2011

BIOTRONIK SE & Co. KG, a leading manufacturer of cardiac devices, announced today that the last chronic heart failure (HF) patient was enrolled in IN-TIME at the Schwabing Clinic in Munich, Germany, with principle investigator Professor Stefan Sack, MD.

IN-TIME is a prospective, multicenter, international clinical trial that randomized 720 patients to assess the influence of BIOTRONIK Home Monitoring^® on the established Packer Score: a composite of all cause mortality, unplanned hospitalization for worsening HF, New York Heart Association (NYHA) class status and patient global self-assessment. The study will contribute significantly to today's evidence-based value proposition of BIOTRONIK Home Monitoring^®.

"Death or hospitalizations due to worsening HF are often preceded by an onset of atrial or ventricular arrhythmia and/or distinct trends of parameters such as activity and heart rate variability," commented Professor Gerhard Hindricks, MD, University Heart Center, Leipzig, Germany, and coordinating clinical investigator of IN-TIME. "BIOTRONIK Home Monitoring^® is the only available solution that has the capability of facilitating such early detection for some of these trends in cardiac device patients and thus may offer physicians the possibility to intervene in time to prevent serious or even fatal events."

"IN-TIME builds upon the existing substantial body of robust clinical evidence that has already demonstrated the unique abilities of BIOTRONIK Home Monitoring^® to provide continuous patient monitoring, to minimize in-office follow-up visits and to detect health status changes and technical challenges early - while being associated with a very high degree of patient satisfaction and the potential to reduce costs for the healthcare system," commented Marlou Janssen, Global Vice President of Marketing and Sales at BIOTRONIK. "It is a clear demonstration of our commitment to lead the industry in establishing clinical evidence for HF therapies and remote monitoring of cardiac device patients. BIOTRONIK has a long-standing legacy of engineering quality solutions, and we firmly believe that there is no better way to demonstrate the reliability and possibilities of our therapies than with clinical investigations of such a high evidence standard as IN-TIME."