Boston Scientific receives US FDA approval for Resonate family of high-voltage devices

Boston Scientific Resonate

The US Food and Drug Administration (FDA) has approved Boston Scientific’s Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) systems.

The approval includes new features in the Resonate devices including SmartCRT technology with Multisite Pacing capability for multi-electrode pacing, and compatibility with the HeartLogic heart failure diagnostic service to help physicians improve heart failure management.

All Resonate devices are powered by the company’s EnduraLife battery technology, which boasts nearly twice the usable battery capacity as certain competitive devices. Recent guidance issued by the UK’s National Institute for Health and Care Excellence (NICE) in March 2017 recommended the use of EnduraLife-powered CRT-Ds to reduce the number of avoidable replacement procedures a patient may have to undergo, thereby offering improved outcomes for patients and potential savings to the National Health Service (NHS) in England of approximately £6 million in the first five years.

The company has initiated a series of clinical trials, the SMART Registry, SMART CRT Study and SMART MSP, to investigate the response to CRT therapy with SmartCRT technology, which is designed to help physicians optimise where, when, and how to pace the lower chambers of the heart.

“These trials will add to the body of evidence showing CRT therapy can be tailored to individual patient characteristics at the time of implant, while adjusting device programming solutions over the life of the device without fear of adversely draining the device battery and causing unnecessary replacement procedures,” says Michael Gold, principal investigator of the SMART CRT study and the Michael E Assey professor of medicine at The Medical University of South Carolina, Charleston, USA.

This FDA approval follows the February 2017 CE Mark and subsequent commercialisation for the Resonate family of ICD and CRT-D devices.