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FDA expands indication for clot retrieval devices to treat acute ischemic stroke
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The FDA announced that it is now allowing two clot retrieval devices to be used in a broader population of patients with acute ischemic stroke.
The devices (Trevo, Concentric Medical) were first cleared by the FDA in 2012 for removal of clots and restoration of blood flow in patients with acute ischemic stroke who could not receive tissue plasminogen activator or did not respond to it. The indication has now been expanded to allow the devices to be used in patients after administration of tissue plasminogen activator (tPA), the agency stated in a press release.
According to the release, approval was based in part on a study comparing 96 patients treated with the devices and tPA with 249 patients treated with tPA and standard medical management, in which 29% of patients from the device group were functionally independent 3 months after stroke vs. 19% of patients from the control group.
The FDA stated in the release that risks associated with the devices include failure to retrieve the clot and malfunctions such as breakage and navigation difficulties.
“This is the first time FDA has allowed use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared with the use of tPA alone,” Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in the release. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”
Disclosure : Peña is an employee of the FDA.