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Medical Devices / Submissions and Approvals

FDA OKs Device for Treating Heart Failure

March 25, 2019

The FDA approved Impulse Dynamics’ Optimizer Smart system, an implantable pulse generator designed to treat moderate to severe heart failure.

The device treats patients who are unable to use other heart failure devices, such as cardiac resynchronization therapy. The device is implanted under the skin in the upper left or right chest area and attached to three leads implanted in the heart.

After implantation, the physician tests and programs the device, enabling it to give electrical impulses to the heart during regular heartbeats and assist in squeezing.

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