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May 9, 2017

FDA grants approval to Boston Scientific’s Resonate ICD and CRT-D defibrillators

The US Food and Drug Administration (FDA) has granted approval to medical solutions provider Boston Scientific’s Resonate line of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) systems.

The US Food and Drug Administration (FDA) has granted approval to medical solutions provider Boston Scientific’s Resonate line of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) systems.

The approval covers the devices’ new features such as SmartCRT technology with Multisite Pacing capability and compatibility with the HeartLogic Heart Failure Diagnostic Service.

The technology is meant for multi-electrode pacing, while HeartLogic is used to improve heart failure (HF) management.

The entire line of Resonate devices are powered by Boston Scientific’s EnduraLife Battery technology.

EnduraLife comes with two-times the usable battery capacity, which is considered to be useful to meet the lifelong needs of patients undergoing ICD or CRT therapy.

"We are changing the treatment landscape by combining industry-leading device longevity with innovative solutions that will provide clinicians with tools to manage heart failure more effectively."

Boston Scientific Rhythm Management and Global Health Policy senior vice-president and chief medical officer Kenneth Stein said: "We are changing the treatment landscape by combining industry-leading device longevity with innovative solutions that will provide clinicians with tools to manage heart failure more effectively.

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"Our post-approval studies for the HeartLogic service, including MANAGE-HF, will gather additional evidence to illustrate how these alerts, which detect impending heart failure decompensation, can improve patient outcomes." 

The ability of SmartCRT technology to enhance response to the CRT therapy was demonstrated in the SMART Registry, SmartCRT and SMART-MSP clinical trials.

In February, Boston Scientific secured the CE Mark and started commercialising the Resonate ICD and CRT-D systems.

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