FDA grants expanded indication for use of Trevo Retriever clot removal device for use within 24 hours.- Stryker

The FDA has expanded the indication for Stryker's Trevo Retriever as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset � increasing the treatment window by 18 hours. The expanded indication of Stryker's clot-removal device is in line with the recently updated treatment guidelines from the American Heart Association and American Stroke Association, and has the potential to reduce disability and improve quality of life for tens of thousands of additional stroke patients each year.

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 six hours after symptom onset.

Comment:The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today�s expanded indication increases the amount of time that the device can be used once the symptoms are present.