The US Food and Drug Administration has granted marketing approval for 2 Trevo (Concentric Medical, Inc.) clot retrieval devices to be used in ischemic stroke – the first of their kind approved to be used in conjunction with intravenous tissue plasminogen activator (IV tPA).1
The Trevo device was previously approved for clot removal in patients with contraindications to IV tPA treatment or those who did not respond to the drug. The current approval applies to the Trevo ProVue and XP ProVue retrievers, according to a letter from the Department of Health and Human Services.
The marketing approval comes after several clinical trials—including MR CLEAN,2 EXTEND-IA,3 and SWIFT PRIME4—showed that treatment with endovascular therapy plus standard IV tPA treatment led to better functional outcomes after stroke.
In a clinical trial, 29% of patients treated with a Trevo device, IV tPA, and medical management were deemed functionally independent, with no symptoms or little disability compared with 19% of patients who were treated with IV tPA and medical management alone.
Use of the retriever devices must follow administration of IV tPA within 3 hours of symptom onset. The devices can be used within 6 hours of treatment onset.
Adverse events associated with Trevo devices include failure of thrombectomy and device breakage or navigation problems resulting in damage to blood vessels, perforation, or hemorrhage.
- FDA allows marketing of clot retrieval devices to reduce disability in stroke patients [news release]. US FDA Newsroom; September 2, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm519042.htm
- Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11-20.
- Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-1018.
- Saver JL, Goyal M, Bonafe A, et al. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285-2295.