Impulse Dynamics has received FDA approval for its Optimizer Smart system for the treatment of patients with moderate-to-severe chronic heart failure who cannot be treated with other heart failure devices, such as cardiac resynchronization therapy, to restore a normal heartbeat timing pattern.
There are few treatment options for patients with moderate-to-severe chronic heart failure. The Optimizer Smart system received a breakthrough device designation as it treats a life-threatening disease and addresses an unmet medical need in patients who do not achieve sufficient benefits from standard treatment and who have no alternative treatment options.
Approximately 5.7 million people in the U.S. have heart failure. To treat the underlying causes and reduce symptoms such as fatigue and swelling, doctors may prescribe medications like angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, or beta blockers to lower blood pressure and reduce strain on the heart.
The Optimizer Smart system is comprised of an implantable pulse generator, a battery charger, programmer, and software. The generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart. After implantation, a physician tests and programs the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s ability to squeeze.
Approval of the device was based on data from two randomized, multicenter clinical trials that included 389 patients with moderate-to-severe heart failure. All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant. Those who received the implant showed improvement in the distance they could walk during walking tests of six minutes. In addition, they showed improvements regarding the extent of heart-failure symptoms’ impact on quality of life and how much those symptoms impede daily physical activities compared to patients receiving only medical therapy.
The Optimizer Smart system is indicated to improve six-minute hall walk distance, quality of life, and the functional status of particular patients with heart failure. These include patients with a pronounced limitation of physical activity and who remain symptomatic in spite of 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 of 25–45%, which is below the normal ejection fraction of 55–75%.
Potential complications associated with the Optimizer Smart system include infection, bleeding, worsened heart failure, or problems with the device itself, such as dislodgement or fracture of the leads implanted in the heart.
Source: FDA, March 21, 2019