Boston Scientific received the U.S. Food and Drug Administration (FDA)’s approval for MRI conditional labeling of its Resonate implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems with HeartLogic Heart Failure Diagnostic.
The devices are now approved for use in an MRI environment.
HeartLogic Heart Failure Diagnostic alerts physicians of worsening heart failure in patients weeks in advance, using data from sensors that evaluate heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity. The device has a sensitivity rate of 70 percent and can provide an average of 34 days advance notice of an impending heart failure event.
“The HeartLogic Diagnostic provides physicians the ability to pivot from reactive heart failure treatment to proactive care with a goal of improving patient outcomes and reducing heart failure-related hospitalizations,” said Kenneth Stein, MD, senior vice president and chief medical officer of Boston Scientific's Rhythm Management and Global Health Policy. “We believe the new features included in this family of devices offer physicians an unprecedented level of confidence when caring for patients with heart failure.”
The new devices also combine the company’s SmartCRT Technology with its EnduraLife Battery which are designed to help physicians customize pacing of the lower chambers of the heart and the ability to tailor device settings according to patient needs.