The Trevo devices, which are inserted into the blood vessel through a catheter to remove the clot, should be used within six hours of the stroke’s onset and only after the clot-dissolving drug — also known as tissue plasminogen activator or t-PA — is administered.
A recent clinical trial showed patients treated with both t-PA and the device reduced paralysis, speech difficulties and other stroke disabilities compared to patients treated with the drug alone.
The FDA approved the Trevo devices, developed by Concentric Medical in Mountain View, Calif., in 2012 for use in stroke patients who could not receive or did not respond to t-PA.
“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health.
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