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FDA Quadruples Treatment Window for Clot Retrieval Device

Posted 16 February 2018 | By Michael Mezher 

FDA Quadruples Treatment Window for Clot Retrieval Device

The US Food and Drug Administration (FDA) on Thursday announced it has expanded the treatment window for Concentric Medical's Trevo clot retrieval device from six to 24 hours after the onset of symptoms.

"Time is critical following the onset of stroke symptoms. Expanding the treatment window from six to 24 hours will significantly increase the number of stroke patients who may benefit from treatment," said Carlos Peña, director of the Division of Neurological and Physical Medicine Devices at the Center for Devices and Radiological Health (CDRH).

Specifically, the device is indicated to remove blood clots in patients with acute ischemic stroke, who cannot receive or did not respond to tissue plasminogen activator (t-PA) therapy, and in certain patients in addition to t-PA within 24 hours of the onset of symptoms.

FDA says it expanded the device's use after reviewing data from a clinical trial that compared 107 patients treated with the device to 99 patients who only had medical management of their symptoms.

"About 48% of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke compared to 13 percent of patients who were not treated with the Trevo device," FDA said.

The device also carries some risks, including causing blockage in new territories in the brain, arterial dissections, vascular perforations and access site complications at the femoral artery where it enters the body.

FDA


Categories: Regulatory News

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