Thursday, April 2, 2020

Thursday, April 2, 2020

FDA approves Optimizer Smart System for heart patients

The U.S. Food and Drug Administration estimates that nearly 6 million Americans have heart failure — the organ can’t keep up with their bodies’ needs.

Some of those with mild-to-severe chronic heart conditions may be getting relief soon, however, after the agency approved the Optimizer Smart System for those who cannot tolerate or do not respond to other therapies.

In a press release issued March 21, the agency said it had approved the Optimizer system through its Breakthrough Device Program, which “fast tracks” devices through the usually lengthy and cumbersome approval process.

To qualify as a breakthrough device, apparatuses such as the Optimizer Smart System need to demonstrate they can provide a benefit to patients who have seriously debilitating or life-threatening conditions, are unable to benefit from currently available treatments and have no other options available to them.

The Optimizer Health System is targeted to people with chronic heart failure who have severely restricted mobility and quality of life because their hearts do not pump blood efficiently enough, and who either have not responded to available treatments or who have underlying health conditions, such as diabetes, that contraindicate available therapies.

The Optimizer system is an Implantable Pulse Generator (IPG) that is inserted into the chest, connected to electrodes that are in turn connected to the patient’s heart. Unlike a pacemaker, the IPG monitors the heart’s activity and when it detects the heart needs activation it delivers impulses that stimulate the tissue itself rather than delivering what are known as “excitatory” stimuli itself.

The device comes with a charger as well as a monitor that health professionals can use to adjust the IPG’s settings.

According to the FDA’s release, people with chronic heart failure who are age 18 and over and who do not respond to other therapies might find this device helps them “perform normal daily activities, [increase] distance walked, and [improve] quality of life.”

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