FDA approves Optimizer Smart system for heart failure

The FDA has approved the Optimizer Smart system, from Impulse Dynamics, for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is indicated to improve six-minute hall walk distance, quality of life and functional status of certain heart failure patients. These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy. Patients should also have a regular heart rhythm, not be candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction (the total amount of blood pumped out in each heart beat) of 25 to 45 percent, which is considered below the normal ejection fraction of 55 to 75 percent. Potential complications associated with the use of the device include infection, bleeding, worsened heart failure or problems with the device itself such as a dislodgement or fracture of the leads implanted in the heart.

The FDA evaluated data from two randomized, multi-center clinical trials with a total of 389 patients with moderate-to-severe heart failure. All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements on standard assessments to measure heart failure symptoms, such as how much the symptoms affect a patient’s quality of life and how much the symptoms impede daily physical activities compared to those who received only medical therapy.