CE Mark Indications & Patient Selection
Approximately 70% of patients with NYHA Class III CHF have normal QRS duration.
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.
For countries that recognize the CE Mark designation, 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.
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.
for NYHA Class III-IV heart failure patients
- who have a left ventricular ejection fraction ranging from 25% to 45%
- who remain symptomatic despite guideline directed medical therapy
- who have normal QRS duration (<130ms)
- and who are not indicated for Cardiac Resynchronization Therapy (CRT)
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.