FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

FDA Advisory Committee Feature image

The first FDA device advisory panel to address a product on FDA’s breakthrough pathway overwhelmingly recommended approval of the novel heart-failure device. The recommendation came despite panel uncertainty during a Dec. 4 meeting as to whether there was enough trial data to prove safety and effectiveness.

Members of FDA’s Circulatory System Devices panel voted 12-1 that Impulse Dynamics NV’s Optimizer Smart System is safe; 11-2...

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