October 27, 2021 — Impulse Dynamics announced the U.S. Food and Drug Administration approved a modification of labeling for the Optimizer Smart medical device, allowing the removal of “normal sinus rhythm” (NSR) from the indications for use statement. Since heart failure patients are no longer required to be in NSR at the time of Optimizer implant, heart rhythm does not impose any restrictions on patients eligible for Optimizer implant, thereby vastly increasing the number of patients who can be treated with CCM therapy.