Lake Oswego, Ore. – May 14, 2009 – BIOTRONIK, Inc. announced that the REPLACE registry results were presented today at Heart Rhythm 2009 during the Late Breaking Clinical Trials session. The REPLACE Registry is a multi-center trial designed to provide physicians the data they need in advising patients and deciding on replacement of cardiac rhythm management devices.
The REPLACE registry collected data on patients who planned to have only their cardiac rhythm device, of any manufacturer, such as a pacemaker or implantable cardioverter defibrillator (ICD), replaced. Sponsored by BIOTRONIK, the prospective, multi-center trial included 1,750 patients with devices from all cardiac rhythm management (CRM) industry manufacturers.
The trial was designed to define the complication and infection rates associated with all cause device replacement. The trial also collected data on predefined major and minor complications, which could shape clinical practice guidelines for elective device replacements.
“This prospective registry, due to the rigorous design, will become the gold standard for comparison,” stated Dr. Jeanne Poole, M.D., Director of Electrophysiology, University of Washington, and the national Principal Investigator of the REPLACE registry.
The REPLACE registry will provide the medical community exactly the information they have been looking for when considering the risks and benefits associated with performing device replacement procedures.
“BIOTRONIK is committed to studies such as REPLACE that contribute valuable, patient-focused information to all parties concerned with improving patients’ quality of life,” said Jake Langer, President of BIOTRONIK, Inc. Dr. Marye Gleva, who served as the chair of the Events Committee, expressed her gratitude to the patients, investigators and coordinators who participated in the two-year trial. “Their commitment was integral to the study’s success,” said Dr. Gleva, M.D., of Washington University School of Medicine in St. Louis, MO.
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.