FDA Approves Expanded Treatment Window for Clot Retrieval Device in Acute Ischemic Stroke
The Trevo device was previously approved for use within 6 hours of stroke symptom onset when used in combination with IV tPA.
The US FDA has approved the use of the Trevo clot retrieval device for up to 24 hours after symptom onset in certain patients presenting with acute ischemic stroke. The device, which is indicated as intial therapy for ischemic stroke when used in conjunction with tissue plasminogen activator (tPA), was previously approved for use within 6 hours of symptom onset.
The extended indication allows for the use of the Trevo device in a much broader group of paitents who might previously not have met criteria for endovascular treatment.
“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA's Center for Devices and Radiological Health, in a press release.1 “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”
The extended approval was based on data from the recently published DAWN trial,2 which compared disability outcomes in patients who received thrombectomy with the Trevo device plus standard care or standard care alone (ClinicalTrials.gov Identifier: NCT02142283). At 3 months, mean utility-weighted modified Rankin scale score was 5.5 in the thrombectomy treated group and 3.4 in the standard of care group (adjusted difference via Bayesian analysis, 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999). Rate of functional independence at 90 days was 49% in the thrombectomy group compared with 13% in the standard of care group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999).
Risks and adverse events associated with use of the Trevo device include cerebral embolization, arterial dissections and vascular perforations, access site complications, and failure to retrieve the clot.
Disclosures: Clinical trial NCT02142283 was funded by Stryker Neurovascular, the manufacturer of the Trevo clot retrieval device.
- FDA expands treatment window for use of clot retrieval devices in certain stroke patients [news release]. Silver Spring, MD: US FDA newsroom. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm?
- Nogueira RG, Jadhav AP, Haussen DC, et al. Thrombectomy 6 to 24 hours after stroke with a mismatch between deficit and infarct. N Engl J Med. 2018; 378:11-21.