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Boston Scientific's Resonate Devices With HeartLogic Heart Failure Diagnostic

Boston Scientific Corp. (BSX) Monday said it has launched the Resonate family of implantable cardioverter defibrillator or ICD and cardiac resynchronization therapy defibrillator oe CRT-D systems featuring the HeartLogic Heart Failure Diagnostic to help physicians improve heart failure management.

The new devices, which are approved by the U.S. Food and Drug Administration for conditional use in a magnetic resonance imaging or MRI environment, also combine the company's SmartCRT Technology with EnduraLife Battery Technology to improve patient management through personalized care.

The MR-conditional labeling allows patients implanted with specific models of the company's Resonate family of devices to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.

This capability extends beyond the Resonate family and includes those patients who were previously implanted with AUTOGEN, DYNAGEN, INOGEN ICD and CRT-D devices. MRI approval was based on clinical trial results from the global ENABLE MRI study, which was completed earlier this year.

The company said the newly introduced HeartLogic Diagnostic alerts physicians of worsening HF by combining data from sensors evaluating heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity.

Kenneth Stein, of Boston Scientific, said, "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."

by RTT Staff Writer

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