Scientists have stated that these devices must be implemented with six hours of the onset of the symptoms. | File photo
+ Technology/Innovation
Amanda Rupp | Sep 7, 2016

FDA approves clot retrieval devices for stroke treatment

Officials with the U.S. Food and Drug Administration recently granted marketing approval for two Trevo clot retrieval devices to treat strokes because of blood clots (ischemic) and to decrease speech difficulties, paralysis and similar stroke disabilities.

Scientists have stated that these devices must be implemented with six hours of the onset of the symptoms. They should only be used after patients have received treatments with clot-dissolving drugs, like t-PA or tissue plasminogen activator. These should be given up to three hours after the symptoms have started to manifest.

“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,” Dr. Carlos Peña, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”

The FDA first cleared the device in 2012. Its goal is to remove blood clots so that stroke patients can have restored blood flow. With this new marketing approval, the device can be used for even more patients throughout the U.S.

Organizations in this story

More News