BIOTRONIK Announces Start of Landmark 1,750 Patient Clinical Trial Evaluating the Complication Rates Associated with Implantable Device Replacement Surgeries

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--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.”

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