FDA Approves Breakthrough Heart Failure Device

More than 5 million American adults are living with heart failure according to the Centers for Disease Control and Prevention but good treatment news may be on the horizon for patients with chronic, moderate-to-severe heart failure.  The FDA has approved a new device for treating these patients who are not suited for treatment with other devices.  Because the innovation treats a life-threatening disease for people with no alternatives, the FDA gave the system a breakthrough designation, expediting its availability.

Heart failure occurs when the heart is unable to pump enough blood and oxygen to support the other organs in the body.  Having coronary heart disease, high blood pressure or diabetes increases the risk for developing heart failure as do unhealthy habits like smoking, eating a high fat, high sodium diet, being overweight and not getting enough exercise. 

People with heart failure can live a longer and better quality of life by receiving an early diagnosis and treatment including taking medications, lowering sodium intake and getting daily physical activity.   Symptoms of heart failure including shortness of breath during regular daily activites, trouble breathing while laying down, weight gain, swelling in the feet, legs, ankles or stomach and feeling generally weak or fatigued. 

The Optimizer Smart system implant, manufactured by Impulse Dynamics, was found to improve quality of life for patients with heart failure in two randomized multi-center clinical trials.  Patients were able to improve their 6-minute walk distance as a result of the implanted device which delivers electrical pulses to the heart during regular heart beats to help boost the heart’s ability to pump blood.   The device is implanted under the skin in the upper left or right area of the chest and is connected to three leads implanted in the heart. 

The Optimizer system does have potential complications including infection, bleeding, worsened heart failure or problems with the device itself.   Learn more about the Optimizer System by following this link to the Impulse Dynamics website.