Biotronik Initiates Trial on Complication Rates with Implantable Device Replacement
July 24, 2007 – Biotonik announced that it has enrolled the first patient and largest trial, REPLACE Registry, which focuses on the complications associated with replacements and system upgrades of implantable pacemakers and defibrillators, and is designed to collect important data currently lacking, on risks associated with device generator replacements.
The 1,750 patient registry will utilize FDA approved devices irrespective of the manufacturer. The study represents BIOTRONIK's continued commitment to the medical field of cardiology. Dr. Haffajee indicated that such a registry is long overdue and stated "the actual complication rates, the type of complications, some of which are life threatening, are often unreported and have never been collected in a prospective fashion in an unbiased registry."
"REPLACE is a very important prospective study for physicians who implant these devices. It is well designed to collect important data currently lacking, on risks associated with device generator replacements. With the growing volume of defibrillators implanted for primary prevention purposes the study will provide a better understanding of the risks that can be anticipated for elective generator replacements or system upgrades," said Dr. Jeanne E. Poole, Director of Electrophysiology at University of Washington and National Principal Investigator for the REPLACE Registry.
The REPLACE Registry will be conducted in 75 to 100 centers across the United States, and will be monitored independently by a Clinical Events Committee chaired by Marye Gleva, M.D, Electrophysiologist at Washington University School of Medicine in St. Louis.
For more information: www.biotronik.com