Press release

New diagnostic device for complete wireless remote patient monitoring with BIOTRONIK Home Monitoring®

Berlin, Germany, January 6, 2009 -- BIOTRONIK SE & Co. KG, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, today announced the first implantations of BIOTRONIK’s new leadless cardiac monitoring device performed by a team of physicians led by Professor Dr. Gerhard Hindricks, Director, Electrophysiology Department at the Leipzig Heart Center in Leipzig, Germany.
 

New leadless cardiac monitoring device for continuous accurate detection and recording of cardiac arrhythmias

The new implantable cardiac monitoring device is based on the BIOTRONIK’s new unified platform technology and provides advanced detection of atrial fibrillation (AF) and other abnormal heart rhythms in combination with BIOTRONIK’s unique Home Monitoring wireless technology. Implanted subcutaneously, without the need for any electrodes placed in the patient’s heart, the new device provides physicians with important clinical and diagnostic information about their patients’ heart condition. It is able to accurately detect and document numerous types of cardiac arrhythmias, e.g. AF or heart block, which often can be identified as root causes for unexplained symptoms such as palpitations or syncope. Furthermore, it enables therapy optimization and surveillance of success and medication after AF ablation in patients without an indication for a pacemaker or an implantable cardioverter defibrillator (ICD).

The new BIOTRONIK cardiac monitoring device uses several sensing vectors allowing for highest signal quality independently from the device position within the patient’s body, which simplifies the implantation procedure and ensures the most accurate detection of abnormal heart rhythms, especially atrial arrhythmias. Arrhythmias detected by the device are recorded and sent automatically and wirelessly to the CardioMessenger® patient device, which then uses the cellular network to transmit all event and trend data to the internet-based BIOTRONIK Home Monitoring® Service Center. On a secure website the physician can immediately evaluate the CardioReport that provides all relevant EGM recordings and long-term statistics in a consolidated and easy-to-read format.    

“Early detection of re-occurrence of atrial fibrillation after ablation therapy remains a major clinical challenge,” stated Professor Dr. Hindricks, Leipzig Heart Center, Leipzig, Germany, who led the first implantation procedures. ”The new device combined with the unique early detection capabilities of BIOTRONIK Home Monitoring® may allow us to immediately react on any kind of atrial arrhythmias after the initial AF ablation procedure in order to avoid further progression of heart remodeling and deterioration of overall heart function.”
 

Early detection of AF with BIOTRONIK Home Monitoring®

AF is a supraventricular tachyarrhythmia characterized by uncoordinated atrial activation with consequent deterioration of atrial mechanical function. It is the most common arrhythmia in clinical practice, accounting for approximately one-third of hospitalizations for cardiac rhythm disturbances and is associated with an increased long-term risk of stroke, heart failure and all-cause mortality. It has been estimated that 2.2 million people in the United States and 4.5 million across Europe have paroxysmal or persistent AF.

BIOTRONIK Home Monitoring® is the first and only remote patient monitoring system that has received FDA and CE approvals for early detection and notification of both symptomatic and asymptomatic arrhythmic events, such as atrial fibrillation, and device system anomalies allowing for earlier physician intervention. It allows clinicians to access their patients’ daily updated data from anywhere at any time enabling early intervention to improve patient care. BIOTRONIK Home Monitoring® together with this leadless cardiac diagnostic device offers a unique daily protection for advanced patient care.

“BIOTRONIK’s new cardiac monitoring device will complete our innovative product portfolio and will improve the patients’ quality of life,” stated Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. “In combination with the completely wireless BIOTRONIK Home Monitoring capabilities and its approved early detection, it sets the stage for an improved AF Management and offers significant advancement in the diagnosis and care of patients at risk of AF.”
 

About BIOTRONIK Home Monitoring®

BIOTRONIK was first to develop and introduce, an internet-based, wireless remote monitoring system using the GSM telephone network. Today, more than 230,000 BIOTRONIK Home Monitoring® systems have been implanted, in more than 55 countries worldwide helping to optimize patient care. BIOTRONIK Home Monitoring® is available across the entire BIOTRONIK product portfolio of pacemakers, ICD and CRT devices enabling remote device follow up at any time from anywhere in the world.
BIOTRONIK’s Home Monitoring technology has been nominated for the prestigious German Federal President’s “Deutscher Zukunftspreis” (German Innovation Award) for its pioneering achievement in medical technology.
 

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 5,000 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.

1. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation


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