CE Mark Indications & Patient Selection

The Optimizer® Smart system received FDA approval on March 21, 2019. The device has been approved in countries covered by the CE mark since October 3, 2016
The Optimizer® Smart Mini system received FDA approval on July 2021. The device has been approved in countries covered by the CE mark since February, 2022

The OPTIMIZER Smart System is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not indicated for Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.

The OPTIMIZER Smart Mini System is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, are not indicated for Cardiac Resynchronization Therapy (CRT), and have a left ventricular ejection fraction ranging from 25% to 45%.

The reader is referred to Abraham W et al., 2018 (JACC HF) and Anker S et al., 2019 (EJHF) for data supporting the above Indications for Use statement. Three publications (Kuschyk et al., 2015 ; Liu et al., 2016; Kloppe et al., 2016) demonstrate 109 cumulative years of long term follow up in over 200 patients. Moreover, data is available for long-term follow from 2 registry studies (Mueller et al., 2017 and Anker S et al., 2019) encompassing 283 patients for up to 3 years of follow up. Continued assessment of safety and effectiveness for the long-term is being conducted in on-going post-market studies.

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