The FDA has approved another one of its breakthrough devices: an implant from Impulse Dynamics designed for patients with chronic heart failure who aren’t able to use a pacemaker or standard cardiac resynchronization therapy.
The device delivers electrical impulses timed to the refractory period of natural heartbeats to help boost the strength of the heart’s muscle contractions and push more blood to the body, rather than regulating the organ’s rhythm.
The Optimizer Smart system consists of an implantable pulse generator with three leads connected to the heart, plus a battery charger, programming device and software.
The system is indicated for improving six-minute hall walk distances, quality of life and the functional status of certain heart failure patients—namely ones with limited physical activity and who remain symptomatic after other treatments, the FDA said in a statement.
It’s also designed for those with a left ventricular ejection fraction—or the percentage of blood discharged from the heart with every beat—of between 25% and 45%, well below the norm of 55% to 75%.
According to the FDA, the device is designed to address a significant unmet medical need, with about 5.7 million people in the U.S. suffering from heart failure—while Impulse Dynamics estimates that only 30% of chronic patients are candidates for CRT.
The agency first granted the system a breakthrough device designation in 2015, and last December an FDA advisory panel recommended approval with a unanimous vote.
In a statement, Impulse Dynamics said it plans to launch the device in the U.S. later this year and is conducting ongoing clinical trials to evaluate the therapy in other heart failure populations.