Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA.
The federal watchdog reviewed the order, and said that on September 2 it issued an order to reclassify the device types, given the generic name of neurovascular mechanical thrombectomy devices for ischemic stroke treatment, as Class II.
In relabeling the devices, the FDA identified 5 possible risks, including adverse tissue reactions, infections, tissue or vessel damage, stroke progression and emboli development.
To manage the risks, the agency laid out specific measures required. Biocompatability evaluations will be required to mitigate issues with adverse tissue reactions, while sterility testing, shelf-life testing and labeling will be required to mitigate infection risk, according to an FDA release.
Non-clinical performance testing, clinical performance testing and labeling will be required to mitigate tissue or vessel damage, including dissection, perforation and hemorrhage, respectively. To mitigate stroke progression and possible emboli, the FDA will require non-clinical and clinical performance testing and labeling.
In September, the FDA granted expanded indications to Concentric Medical for its Trevo devices, clearing them as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities.
The indications expand previous clearances for the devices, won in 2012, which cleared the retrievers for removing blood clots and restoring blood flow in stroke patients who can’t be treated with tissue plasminogen activator or for patients who didn’t respond to t-PA therapy.