CE Mark Indications & Patient Selection
The Optimizer® Smart system has been approved in countries covered by the CE mark since October 3, 2016. The device received FDA approval on March 21, 2019.
The OPTIMIZER Smart system is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic 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 and prevent hospital admissions in patients with symptomatic left heart failure in carefully selected patients and in the hands of dedicated heart failure cardiologists.
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.