Stryker's Trevo Retriever has met the primary effectiveness endpoint, achieving better post-device revascularisation compared to the Merci Retriever (86.4% in the Trevo Retriever arm compared to 60% in the Merci Retriever arm) in the Trevo 2 clinical trial.
The Trevo 2 trial was a pivotal, randomised, core lab, adjudicated, clinical trial that enrolled 178 patients across 27 institutions in the US and Europe to determine the safety and efficacy of Trevo Retriever for removing clots from ischemic stroke patients.
The Trevo Retriever system employs Stentriever technology for retrieving clots from the neurovasculature of ischemic stroke patients.
At 90 days, the rate of functional independence for patients treated with the Trevo Retriever was better than for the Merci Retriever. In addition, the Trevo Retriever also demonstrated improvements in National Institutes of Health Stroke Scale (NIHSS) and hospital stays.
Marcus Stroke and Neuroscience Center, US, neuroendovascular division director, Raul Nogueira, said the mechanical thrombectomy device provides an effective tool for revascularising large vessel strokes.
"We now have a fast and very reliable way to remove blood clots in patients with severe and potentially debilitating strokes," Nogueira added.
Oregon Health & Science University, US, neurology vice chair and professor Helmi Lutsep said: "We have traditionally seen poor outcomes for patients with large vessel occlusion strokes, and new devices like the Trevo Retriever represent a much improved treatment option."
Mark Paul, Stryker's neurovascular business president, said: "Our customers and patients need easy and reliable treatment options and we will continue to invest in the development of new technology and high quality clinical trials."
The company intends to submit the Trevo 2 data to the US Food and Drug Administration to seek clearance for the Trevo Pro Retrieve device.