This article is more than 5 years old. Information may no longer be current.
ICD, CRT-D systems receive FDA approval for MRI
Click Here to Manage Email Alerts
Boston Scientific announced that the FDA has approved an MRI labelling for its line of implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems for the management of HF.
The family of systems (Resonate) includes an HF diagnostic tool (HeartLogic) that notifies clinicians of a patient’s worsening HF through the evaluation of thoracic impedance, respiration volume and rate, heart sounds, and heart rate and activity, according to a press release from the company. The device can alert clinicians of an impending HF event in a median of 34 days.
The CRT-D systems feature technology (SmartCRT) that allows clinicians to modify when, where and how to pace a patient’s lower heart chambers through a multi-electrode pacing capability. Updated battery functionality (EnduraLife) gives clinicians the ability to update device settings without draining the battery.
The MANAGE-HF study has recently begun enrolling patients to evaluate the HeartLogic diagnostic technology, according to the press release.
“Through the MANAGE-HF study, we will be able to realize fully the capabilities of the HeartLogic Diagnostic in clinical practice,” Adrian F. Hernandez, MD, MHS, director of health services and outcomes research at the Duke Clinical Research Institute and vice dean for clinical research at Duke University School of Medicine, said in the release. “We look forward to collecting additional data on how the alert can enable improved patient outcomes.”
Disclosure: Hernandez reports he is the principal investigator of the MANAGE-HF study.