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FDA Expands Treatment Time for Clot Retrieval Device

FDA news release; 2018 Feb 15

The US Food and Drug Administration (FDA) recently cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients.

Indications: This device is cleared for use as an initial therapy for strokes due to blood clots (also known as an acute ischemic stroke) to reduce paralysis, speech difficulties, and other stroke disabilities and only as an addition to treatment with a medication that dissolves blood blots called tissue plasminogen activator (t-PA). The device was previously cleared for use in patients 6 hours after symptom onset.

Administration: Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to 3 to 6 mm in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

Adverse reactions: Risks associated with using the Trevo device include a failure to retrieve the blood clot, embolization (blockage) to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral (thigh) artery entry point.

Citation:

FDA expands treatment window for use of clot retrieval devices in certain stroke patients. [news release]. February 15, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm. Accessed March 15, 2018.