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Medical Devices / Submissions and Approvals

FDA Approves Impulse Dynamics’ Heart Failure Device

March 26, 2019

The FDA approved Impulse Dynamics’ implantable Optimizer Smart System for treating heart failure.

The breakthrough device, which received a 12-0 vote from the FDA’s Medical Devices Advisory Committee in December 2018, is intended for patients who have mildly to moderately reduced left ventricular ejection fractions and aren’t eligible for cardiac resynchronization therapy.

The device delivers an electrical pulse just after the heart contracts to modulate the strength of the heart muscle contraction rather than the rhythm.

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