FDA Indications & Patient Selection
Approximately 70% of patients with NYHA Class III heart failure are not indicated for cardiac resynchronization therapy.
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 and 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%.