News | July 23, 2007

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

Related Content

Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Predictive Models May Help Determine Which Patients Benefit From ICDs
News | Implantable Cardioverter Defibrillator (ICD)| July 06, 2017
Two predictive models may help cardiologists decide which patients would most benefit from an implantable cardioverter...
Medtronic Reactive ATP Therapy Slows Progression of Atrial Fibrillation in Real-World Population
News | Atrial Fibrillation| July 03, 2017
Medtronic recently announced that its Reactive ATP therapy slows the progression of atrial fibrillation (AF) in...
Sponsored Content | Videos | Cardiovascular Ultrasound| June 29, 2017
Leyla Elif Sade, M.D., MESC, professor of cardiology at Başkent University, Ankara, Turkey, discusses use of echo for
Biosense webster multielectrode balloon RF ablation catheter

The Biosense Webster multi-electrode balloon RF ablation catheter. Each electrode can have varied power settings to avoid damage to underlying tissues like the esophagus. 

Feature | EP Lab| June 22, 2017 | Dave Fornell
Electrophysiology (EP) technology has been advancing rapidly the past few years with new ablation tools to improve...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers| June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Sponsored Content | Videos | Implantable Cardioverter Defibrillator (ICD)| June 01, 2017
Lucas Boersma, M.D., Ph.D., FESC, St.
Sponsored Content | Videos | Leads Implantable Devices| May 25, 2017
Bruce Wilkoff, M.D., director of cardiac pacing and tachyarrhythmia devices at Cleveland Clinic, discusses advancemen
Overlay Init