FDAnews
www.fdanews.com/articles/10531-fda-approves-clot-retrieval-devices-for-initial-stroke-treatment

FDA Approves Clot Retrieval Devices for Initial Stroke Treatment

September 3, 2016

The FDA approved two Trevo clot retrieval devices for use as part of an initial therapy for strokes that expands the devices’ indication to a broader group of patients.

The first-time approval allows the devices to be used alongside a tissue plasminogen activator (t-PA) to reduce paralysis, speech difficulties and other stroke-related disabilities.

Trevo, manufactured by Concentric Medical, was first cleared by the FDA in 2012 to remove blood clots and restore blood flow in stroke patients who could not receive a clot-dissolving drug or for those patients who did not respond to clot-dissolving therapy. — Cynthia Jessup