FDA Expands Indications for Two Endovascular Stroke Therapies
The US Food and Drug Administration (FDA) announced last week that two already available transcatheter clot removal devices can now be used along with IV tissue plasminogen activator (tPA) to improve functional outcomes in patients with acute ischemic strokes.
Based on the original 2012 approval, the devices—the Trevo ProVue and XP ProVue Retrievers (Stryker Neurovascular)—previously could be used only in patients who could not receive or did not respond to tPA.
The stentrievers should be used within 6 hours of symptom onset following treatment with IV tPA, which itself needs to be administered within 3 hours of symptom onset, according to the FDA.
The expanded indication was supported by data from a trial comparing 96 patients who were treated with a Trevo device in addition to IV tPA and medical management of blood pressure and disability symptoms with 249 who were treated only with tPA and medical management. As reported by the FDA, the rate of functional independence at 3 months was 29% in Trevo-treated patients and 19% in controls.
The FDA reviewed the data through the agency’s de novo premarket pathway.
US Food and Drug Administration. FDA allows marketing of clot retrieval devices to reduce disability in stroke patients.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm519042.htm. Published on: September 2, 2016. Accessed on: September 6, 2016. Related Stories: