Boston Scientific Resonate ICDs, CRT-Ds Get MR-Conditional Labeling

Megan Brooks

September 25, 2017

BOSTON, MA — Boston Scientific has received approval from the US Food and Drug Administration (FDA) for MRI labeling of the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems, the company announced[1].

The FDA approved the devices for conditional use in an MRI environment.

"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," the company said in a statement. This capability also extends to patients implanted with Boston Scientific's Autogen, Dynagen, and 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 Resonate ICD and CRT-D systems include the company's HeartLogic heart-failure diagnostic, which alerts physicians to worsening heart failure in advance of an impending HF event by combining data from sensors evaluating heart sounds, respiration rate and volume, thoracic impedance, heart rate, and activity. Observed sensitivity is 70%, and HF events are detected a median of 34 days in advance, they note.

In addition, all CRT-Ds in the Resonate group of devices contain the company's SmartCRT technology to help physicians customize  pacing of the lower chambers of the heart using the Multisite Pacing capability for multielectrode pacing.

The company has started enrolling patients in the MANAGE-HF study to further evaluate the HeartLogic Diagnostic and has initiated a series of clinical trials to demonstrate improved response to CRT therapy with the SmartCRT technology.

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