Two devices for mechanically removing blood clots now can be used in conjunction with clot-dissolving tissue plasminogen activator (tPA) as an initial therapy for acute ischemic strokes, the US Food and Drug Administration (FDA) announced today.
The devices in question are the Trevo ProVue and Trevo XP ProVue Retrievers, both from Concentric Medical. The FDA first approved this clot-removal technology in 2012 to restore blood flow in patients experiencing strokes who can't receive tissue plasminogen activator (tPA) and patients who don't respond to the drug.
In broadening the indication, the agency said that the Trevo clot retrievers should be used within 6 hours of symptom onset and only after tPA is administered.
"This is the first time FDA has allowed the use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of tPA 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, in a news release. "Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability."
The Trevo clot retrievers are inserted into the occluded blood vessel via catheter. An expandable wire mesh at the distal end grips the clot, which a physician can pull back through the blood vessel along with the device for extraction through a catheter or sheath.
The FDA approved the expanded indication for the Trevo clot retrieval technology on the basis of a clinical trial comparing 96 randomly selected patients treated with the device as well as tPA and medical management of blood pressure and disability symptoms; 249 patients received only tPA and medical management. Of patients undergoing thrombectomy with a Trevo device, 29% were functionally independent 3 months after their stroke. This was the case for only 19% of those forgoing thrombectomy.
The Trevo devices come with the risk of failure to retrieve the clot, malfunctions such as breakage, and navigation problems that can lead to perforated blood vessels.
More information about today's announcement is available on the FDA website.
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Cite this: Trevo Clot Retrievers Approved for Use With tPA - Medscape - Sep 02, 2016.
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