Clot Retrieval Devices FDA-Approved as Initial Therapy for Ischemic Stroke
The Food and Drug Administration (FDA) has granted clearance for marketing of Concentric Medical's two Trevo clot retrieval devices as initial therapy for ischemic strokes to reduce paralysis, speech difficulties, and other stroke disabilities. The clot retrieval devices are intended for use within 6 hours of symptom onset and only after treatment with a clot-dissolving agent (eg, tissue plasminogen activator [t-PA]), which should be given within 3 hours of symptom onset.
The Trevo device was originally cleared by the FDA in 2012 to remove a blood clot and restore blood flow in patients with stroke who could not receive or were unresponsive to t-PA therapy. Today's approval expands the devices' indication to a wider patient population. Prior to this approval, the only first-line treatment for acute ischemic stroke was intravenous t-PA therapy.
The Trevo device is inserted through a catheter into the blood vessel to the site of the clot. When the shaped section is fully expanded (up to 3–6mm diameter), it grips the clot so that the physician can pull it back through the blood vessel along with the device to discard through a catheter or sheath.
The FDA reviewed data from a clinical trial evaluating 96 patients treated with the Trevo device with t-PA and medical management of blood pressure and disability symptoms vs. 249 patients treated with only t-PA and medical management. The study showed 29% of patients treated with the Trevo device had functional independence (ranging from no symptoms to slight disability) 3 months post-stroke vs. 19% of patients treated with only t-PA. The data for Trevo for stroke management was reviewed by the FDA's de novo premarket review pathway.
For more information visit FDA.gov.