Stryker Neurovascular has obtained the US Food and Drug Administration's (FDA) approval for its new clot removal technology, Trevo Pro Retriever.
By utilizing 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, randomized, core lab adjudicated clinical trial, designed to assess the safety and efficacy of Trevo Pro Retrieval system for removing clots from ischemic stroke patients as compared to Stryker’s current Merci Retriever.
The results demonstrated highest rate of revascularization and achieved better post-procedure revascularization than the Merci Retriever (92% in the Trevo Retriever arm compared to 76.7% in the Merci Retriever arm).
The results also showed improvement in the National Institutes of Health Stroke Scale (NIHSS) score and excellent composite safety endpoints and shorter hospital stays.
University of California Los Angeles Medical Center spokesperson and TREVO 2 investigator Gary Duckwiler said Concentric Medical, which is now owned by Stryker, has a long history of partnering with physicians to develop devices specifically designed to remove blood clots from a blocked artery 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 added.
Stryker neurovascular division president Mark Paul said the company is committed to provide 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 added.