The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker Neurovascular’s new clot removal technology, Trevo Pro retriever.
By utilising proprietary Stentriever technology, the Trevo Pro retriever removes blood clots in patients experiencing acute ischemic stroke.
The FDA approval is based on the Trevo 2 pivotal, randomised, core lab adjudicated clinical trial, designed to assess the safety and efficacy of Trevo Pro retrieval system for removing clots when compared to Stryker’s current Merci retriever.
The results demonstrated highest rate of revascularisation and achieved better post-procedure revascularisation than the Merci retriever (92% for Trevo compared to 76.7% for Merci).
The results also showed improvement in the National Institutes of Health Stroke Scale score, excellent composite safety endpoints and shorter hospital stays.
University of California Los Angeles Medical Centre spokesperson and Trevo 2 investigator Dr Gary Duckwiler said Concentric Medical, now owned by Stryker, has long been partnering with physicians to develop devices designed to remove blood clots in the brain.
"The new Trevo Pro retriever is easy to use and very effective at opening blood vessels; allowing physicians to have a significant impact on clinical outcomes," Duckwiler said.
Stryker neurovascular division president Mark Paul said the company is committed to providing new technologies, along with robust clinical evidence, to expand the field.
"As we saw with the Trevo 2 data, this technology is helping physicians and patients, and we are very excited to be able to facilitate advances in medical care with game-changing technology like the Trevo Pro retriever," Paul said.