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FDA issues advisory on appropriate catheters for neurovascular thrombus removal
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The FDA has published an advisory on which catheters are and are not indicated for neurovascular thrombus retrieval.
According to the document, neurovascular thrombus retrieval catheters (product code NRY) are cleared specifically for restoring blood flow or removing thrombus within 8 hours of acute ischemic stroke onset in patients who cannot receive or failed IV tissue plasminogen activator, whereas neurovascular guide catheters (product code DQY) are not cleared.
Neurovascular guide catheters are usually cleared for the purpose of introducing interventional devices into the neurovasculature as a conduit for retrievers, the FDA stated.
The two types of catheters “may be designed with different features (eg, length, diameter, variations in material stiffness distally and proximally),” the FDA stated. “Use of neurovascular guide catheters for thrombus removal may affect the safety and performance, which could result in device failure and/or serious adverse events such as vessel damage, perforation or dissection when used in the most distal regions of the neurovasculature.”
The FDA has received “a small number” of adverse event reports regarding neurovascular guide catheters used to remove thrombus, one of which involved vessel perforation and death, according to the advisory.
“The FDA is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombus removal in patients with acute ischemic stroke,” the agency wrote. “The FDA will continue to be responsive to new technological advances and valid scientific evidence of new indications as part of our premarket review process.”
Health care providers should carefully review the approved indications for each catheter when reading marketing materials and literature on them, and should be aware of differences in device design and the implications those differences may have during attempted thrombus removal, according to the document.