The FDA has approved the start of the FIX-HF-5B confirmatory study for confirming the safety and efficacy of the optimizer III system. This is one of the ongoing studies in the process of achieving FDA approval for the Optimizer III in the US.

Impulse Dynamics has already completed a series of clinical trials, with over 800 patients implanted with the Optimizer III pulse generator and over 8 years of follow-up data available.