FDA Approves Marketing for Clot Retrieval Device

Trevo devices should be used after treatment with tissue plasminogen activator in patients with an ischemic stroke.

The FDA will allow marketing of clot retrieval devices as an early treatment for ischemic strokes to reduce the occurrence of stroke-related disabilities.

Conditions such as atrial fibrillation can increase the risk of ischemic stroke up to 5-fold due to increased clotting in the blood. The 2 Trevo clot retrieval devices are used within 6 hours of initial symptoms following treatment with tissue plasminogen activator (t-PA), a clot-dissolving drug.

Previously, the only first-line treatment was t-PA, which has to be administered within 3 hours of symptoms. The Trevo device received clearance from the FDA in 2012 to remove a blot clots in patients who could not receive or respond to treatment with t-PA, according to a press release.

Expanding the indication of the device to be used alongside t-PA will allow more patients to be treated with the clot retrieval device. The device is inserted through a catheter into the blood vessel and to the site of the blood clot, according to the FDA.

A section at the end of the device is able expand to take hold of the clot. Physicians will then remove it by pulling the clot and the device through the blood vessel.

The FDA expanded its use due to findings from a recent review of a clinical trial, which included 96 patients treated with the device and t-PA and 249 patients who only received treatment with t-PA. Researchers discovered that 29% of patients treated with the device had a range of no symptoms to slight disability 3 months after their stroke compared with 19% of patients treated with t-PA alone, according to the FDA.

Known risks associated with the device are failure to retrieve the clot and device malfunction, which could potentially damage blood vessels, and cause perforation or hemorrhage.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”