Tag: Optimizer Smart

Impulse Dynamics Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System

Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM™ (Cardiac Contractility Modulation) therapy, announced today that it has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart System for […]

FDA approves new device for treating moderate to severe chronic heart failure in patients

SILVER SPRING, Md., March 21, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. […]