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Medtronic begins U.S. arm of Concerto defibrillator study
By Angela McDaniels
Seattle, Feb. 1 - Medtronic Inc. said it has implanted the first Concerto cardiac resynchronization therapy defibrillator in the United States as part of a prospective, non-randomized, multi-center clinical trial.
The trial will enroll up to 425 patients at roughly 50 sites in Europe, the United States and Japan, according to a company news release.
The purpose of the study is to assess the safety and efficacy of atrial defibrillation therapy in patients with a cardiac resynchronization therapy (CRT) device or an implantable cardioverter-defibrillator.
CRT devices send electrical impulses to the heart muscle to resynchronize the contractions of the heart's lower chambers, helping the heart pump blood throughout the body more efficiently and reducing patients' heart failure symptoms, according to the release. CRT defibrillator devices can also deliver a shock to terminate a dangerously abnormal heart rhythm.
The Concerto CRT defibrillator uses Medtronic's Conexus wireless telemetry, which aids in implantation and provides information during in-office follow-up visits.
It also automatically transmits data from the patient's device to a home monitor. The data is then transmitted to the clinician using the Medtronic CareLink Network, the first internet-based system to help physicians and patients better manage chronic cardiovascular disease treated by implantable device therapy, according to the release.
"Wireless transmission of data on how the device and patient's heart are operating, coupled with the device's therapeutic and monitoring features, hold promise for better patient care and more effective device management," the study's principal investigator, David Schwartzman of the University of Pittsburgh Medical Center, said in the release.
Medtronic is a medical technology company based in Minneapolis.
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