FDA approves Resonate family of implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems with longer life batteries.- Boston Scientific

Boston Scientific has received FDA approval for the Resonate family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization 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 (HF) management .

The products all use the EnduraLife battery, a technology Boston Scientific claims has twice the capacity as that used by Medtronic in its Evera XT VR DVBB2D4 device. Boston Scientific has made battery life the centerpiece of its push to sell Resonate devices in Europe. EnduraLife battery makes it feasible to program multipoint pacing at implantation. Multipoint pacing enables physicians to optimize CRT to each patient, cutting the number of non-responders.

This FDA approval follows on the February 2017 CE Mark and subsequent commercialization for the Resonate family of ICD and CRT-D devices. The system has NICE recommendation in the UK.