BIOTRONIK, the leading manufacturer of cardiac devices celebrating its 50th anniversary this year, announced ground-breaking results from the IN-TIME study today at the ESC (European Society of Cardiology) congress. Coordinating investigator of IN-TIME, Professor Gerhard Hindricks, MD, from the Heart Center, University Leipzig, Germany, presented the first results from the study during a hot line session at ESC.
The BIOTRONIK sponsored IN-TIME study is the first randomized, controlled trial worldwide that demonstrated a significant reduction in all-cause mortality in heart failure patients with implant-based remote monitoring. In patients with severely depressed LV-function and NYHA II/III, a significant reduction in all-cause mortality was observed, supported by implant-based BIOTRONIK's Home Monitoring® as compared to standard care. From an estimate based on the Kaplan-Meier curve the mortality at one year follow-up was 3.4% in the home monitoring group and 8.7% in patients with standard care.
"The occurrence of atrial or ventricular arrhythmias or specific trends in certain clinical parameters can often be the first sign of worsening heart failure that leads to hospitalization or death," commented Prof. Hindricks. "BIOTRONIK Home Monitoring® allows physicians to facilitate early detection of clinically relevant events or crucial trends in cardiac device patients. They then have enough notice to intervene in time, thereby preventing serious or even fatal events and effectively supporting the management of heart failure patients."
BIOTRONIK Home Monitoring® rapidly detects deterioration in patients' clinical status and automatically transmits data on a daily basis. Early detection of clinically relevant events, in particular asymptomatic atrial fibrillation, enables the physician to adapt patient therapy at a very early stage.
"Numerous studies have been published over the past few years which have confirmed the clinical and economical benefits of BIOTRONIK Home Monitoring®. Now the IN-TIME study reinforces these excellent clinical outcomes, by, for the first time, demonstrating a reduction in mortality in heart failure patients," commented Christoph Böhmer, President International of BIOTRONIK. "The latest additions in the ESC guidelines indicate that home monitoring will play an even more important role in the future. The European Society of Cardiology recommends device based telemonitoring for early detection of critical events in cardiac patients. BIOTRONIK Home Monitoring® is particularly well suited to serving the heart failure patient population."
About BIOTRONIK SE & Co. KGAs one of the world's leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market -- including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world's first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. This year BIOTRONIK is celebrating its 50th anniversary.
For more information, visit: www.biotronik.com.