Boston Scientific Pacemakers Now Approved For Use in Class I and II Heart Failure

We’ve known for a few years that using Implantable Cardiac Defibrillators (ICDs) works better than conventional medical therapy alone for reducing all-cause mortality, but this therapy was reserved for patients with more severe (NYHA Class III and IV) forms of heart failure. That has changed with the release of the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy), which was sponsored by Boston Scientific.
The study looked at implanting CRT-Ds (Cardiac Resynchronization Therapy – Defibrillator) – biventricular pacemakers to resynchronize and a defibrillator to shock the heart out of Vfib/Vtach – in asymptomatic or mildly symptomatic (NYHA Class I and II) patients that also had wide QRS complexes and left bundle branch block. They found a 35% reduction in all-cause mortality and a 63% reduction in the risk of heart failure events.
In light of this data, the FDA has broadened the indication for Boston Scientific devices like the COGNIS to include intervention in these patient classes.
Press release: Boston Scientific Receives Exclusive Expanded Indication for Its CRT-Ds …