Press release

BIOTRONIK Announces Start of Landmark REPLACE Clinical Trial

LAKE OSWEGO, Oregon. BIOTRONIK today announced that it has enrolled the first patient in the landmark REPLACE Registry, the first and largest prospective trial focusing on the complications associated with replacements and system upgrades of implantable pacemakers and defibrillators independent of the manufacturer. The first United States generator change procedure performed under this protocol was performed at Caritas St. Elizabeth Medical Center, Boston, MA. Dr. Charles Haffajee, Principal Investigator, performed the surgical procedure by replacing a dual chamber ICD that reached Elective Replacement Indication (ERI). The 1,750 patient registry will utilize only devices approved by the U.S. Food and Drug Administration and includes all device models 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.

In an industry with a growing number of device implants due to primary prevention applications as noted by Dr. Poole, coupled with sporadic device advisories notifying clinicians of the potential for adverse device performance, there exists a critical need to characterize complication rates. With the results from this landmark trial, Electrophysiologists and Cardiologists will be better able to make decisions on the risk versus benefit of elective replacement surgeries.

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. Several key co-morbidity variables will be evaluated to further reveal the relative risks inherent in these procedures.

“BIOTRONIK is pleased to sponsor this important trial and to be a part of the industry leading efforts in support of medical research,” said Jake Langer, President, BIOTRONIK, Inc. “The funding of the REPLACE Registry is a key component of BIOTRONIK’s increased participation in the U.S. market.”

The REPLACE Registry was designed by a Steering Committee composed of both academic and private practice Electrophysiologists to capture the information of greatest benefit to implanting physicians. The database, study statistician, Clinical Research Organization, and Clinical Events Committee are all operationally independent of BIOTRONIK, the study sponsor. The REPLACE Registry is currently posted on clinicaltrials.gov.

BIOTRONIK today ranks as one of the leading cardiac rhythm management (CRM) companies, conducting business in over 100 countries worldwide. BIOTRONIK provides complete solutions for diagnosis, treatment and highly developed therapy management in the field of cardiac rhythm management.

 


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