Study Affirms BIOTRONIK Home Monitoring® Leads to Earlier Intervention
Company Announces FDA-Approved, Clinically-Supported Labeling Instructions
Lake Oswego, Ore. - May 13, 2009 – BIOTRONIK, Inc. announced today that the landmark TRUST (Lumax-T/Lumos-T safely reduces routine office device follow-up) study affirms that automatic early detection of clinical events by BIOTRONIK Home Monitoring® leads to earlier intervention than conventional in-office follow-ups.
As a result, the company is updating its labeling instructions to show how physicians can reduce the number of patient visits to their office for routine device follow-up without compromising the quality of care these patients receive.
BIOTRONIK pioneered wireless remote technology more than eight years ago in the United States and is still the leader in this technology today.
TRUST is the first and largest study to test the ability of remote monitoring in reducing in-office follow-ups.
TRUST enrolled 1,443 patients in 105 North American sites in a prospective, randomized controlled trial to determine the system’s ability to provide early detection of arrhythmias, including those that are asymptomatic to the patient.
“TRUST demonstrates that BIOTRONIK Home Monitoring® significantly reduces the need for hospital visits by almost one half, and at the same time, ensures follow-up surveillance and enables prompt medical evaluation of critical cardiac events,” said Dr. Niraj Varma, Cardiac Pacing & Electrophysiology, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH and TRUST Principal Investigator.
Reimbursement for remote patient management has followed adoption of this technology and BIOTRONIK Home Monitoring® is now the only system that has clinical support to show that its remote transmissions may be used as a replacement for in-office device interrogations. Furthermore, the proven safety and efficacy of BIOTRONIK Home Monitoring® will now allow the time between routine, scheduled, in-office follow-ups of BIOTRONIK devices to be extended for many patients.
“BIOTRONIK Home Monitoring® is the only clinically proven system to show equivalency to an in-office follow-up. By allowing the time between in-office visits to be extended to once a year, we are providing physicians with the ability to offer the same level of superior care to each of their patients while allowing additional time to focus on those patients that need their immediate attention,” said Rex Richmond, Vice President of Marketing, BIOTRONIK, Inc.
TRUST is just one example of BIOTRONIK’s commitment to invest in significant clinical trials to further advance patient care. Other landmark trials sponsored by BIOTRONIK include REPLACE, IMPACT, and ECHO-CRT.
Contact: Holly Scerbo
About BIOTRONIK GmbH & Co. KG
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4,500 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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