Impulse Dynamics Optimizer Smart Mini System Receives Expanded Indication in Europe

March 28, 2025—Impulse Dynamics plc announced that it received European CE Mark approval for an expanded indication for its Optimizer Smart Mini system, which delivers the company’s cardiac contractility modulation (CCM) therapy. CCM therapy is now indicated for symptomatic heart failure (HF) patients with diastolic or systolic ventricular dysfunction.

According to the company, this new indication is intended to alleviate debilitating symptoms, improve quality of life, and reduce HF-related hospitalizations for patients with diastolic HF.

In Europe, the Optimizer Smart Mini system is indicated for use in patients aged > 18 years with symptomatic HF caused by systolic and diastolic left ventricular dysfunction despite appropriate medical therapy. CCM therapy, as delivered by the Optimizer system, has been shown to improve clinical status, functional capacity, and quality of life, as well as prevent hospital admissions in patients with symptomatic left HF, advised Impulse Dynamics.

“This expanded indication addresses an important unmet clinical need for patients with diastolic HF or HF with preserved ejection fraction, as it is now also called,” commented Professor Stefan Anker, MD, from Charité University in Berlin, Germany, in the company’s press release. “These patients currently have only a few effective treatment options; therefore, the new development by Impulse Dynamics is most welcome. HF specialists in Europe now have an approved device-based treatment for diastolic HF patients that has been shown to improve quality of life and to reduce their need for HF-related hospitalizations.”