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FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

 
• By Reed Miller

The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.

FDA approved background, 3D rendering, blue street sign
• Source: shutterstock.com

FDA approved Impulse Dynamics NV’s PMA for the Optimizer Smart implantable pulse generator to treat heart failure, one of the first devices designated by FDA as a Breakthrough Device, the agency announced March 21.

Optimizer Smart is about the size and shape of an implantable cardioverter defibrillator (ICD). It is implanted subcutaneously and delivers...

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