The Food and Drug Administration (FDA) has approved the Optimizer Smart System (Impulse Dynamics) for use in patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy (CRT).
The Optimizer Smart System is indicated to improve the 6-minute hall walk distance, quality of life, and functional status of NYHA Class III heart failure patients who have a marked limitation of physical activity and who remain symptomatic despite optimal medical therapy. Eligible patients should have a regular heart rhythm, not be candidates for CRT, and have a left ventricular ejection fraction (LVEF) of 25–45%.
The System is comprised of an implantable pulse generator, battery charger, programmer, and software. The pulse generator is implanted under the skin of the chest and connected to 3 leads implanted in the heart. Once the device is programmed by the physician, electrical impulses are delivered during regular heartbeats to improve the heart’s contractions.
“The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients,” stated Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center.
The approval was based on 2 clinical trials involving 389 patients with moderate-to-severe heart failure. Each patient received optimal medical therapy and 191 also received an Optimizer Smart System implant. Results showed that those who had the implant had improvements in the 6-minute walking test, as well as improvements on assessments of heart failure symptoms (e.g., quality of life), compared with patients who received only medical therapy.
Infection, bleeding, worsened heart failure or device problems may be potential complications associated with the Optimizer Smart System.
In December 2018, an FDA Medical Devices Advisory Committee voted 12-0 on the benefit-to-risk ratio of the device. The Company plans to launch the Optimizer Smart System in the US later this year.
For more information visit FDA.gov.