FDA Indications & Patient Selection
Approximately 70% of patients with NYHA Class III CHF are not indicated for CRT.
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 system is indicated to:
- Improve 6-minute hall walk distance, and
- Improve quality of life, and
- Improve functional status
. . . for NYHA Class III heart failure patients
- who have a left ventricular ejection fraction ranging from 25% to 45%
- who remain symptomatic despite guideline directed medical therapy
- who are in normal sinus rhythm
- and who are not indicated for Cardiac Resynchronization Therapy (CRT)
The Optimizer® Smart system is a unique cardiac device therapy, that was granted Breakthrough Device designation by the U.S. Food and Drug Administration, and then went on to receive a unanimous recommendation for approval based on risk-benefit ratio from the FDA’s advisory panel.