Posted by Michael Wonder on 21 Mar 2019
FDA approves new device for treating moderate to severe chronic heart failure in patients
21 March 2019 - The U.S. FDA 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.
The FDA gave the device a breakthrough device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.
The FDA evaluated data from two randomised, multi-center clinical trials with a total of 389 patients with moderate-to-severe heart failure.
