May 30, 2012 — At the European Stroke Conference in Lisbon, Portugal, Stryker announced the results of the TREVO 2 clinical trial. The study met the primary effectiveness endpoint, with the Trevo Retriever achieving significantly better post-device revascularization than the Merci Retriever (86.4 percent in the Trevo Retriever arm compared to 60 percent in the Merci Retriever arm). The rates of functional independence at 90 days for patients treated with the Trevo Retriever were also better than for the Merci Retriever (40 percent mRS less than or equal to 2 compared to 21.8). Other measures of performance also strongly favored the Trevo Retriever, including improvement in the National Institutes of Health Stroke Scale (NIHSS) and shorter hospital stays.
The results were presented by Raul Nogueira, M.D., director of the neuroendovascular division at the Marcus Stroke and Neuroscience Center in Atlanta. "This new generation of mechanical thrombectomy device provides us with a highly effective tool for revascularizing large vessel strokes," said Nogueira. "We now have a fast and very reliable way to remove blood clots in patients with severe and potentially debilitating strokes."
"This trial shows a significant evolution in stroke care," said Helmi Lutsep, M.D., professor and vice chair of neurology at Oregon Health and Science University in Portland, Ore. "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. Now we need to find additional ways to quickly get patients having a severe stroke to a hospital that can provide comprehensive stroke care."
The results of the TREVO 2 trial are consistent with the earlier TREVO trial, which was conducted in Europe and presented at the International Stroke Congress in February.
"Trials like TREVO 2 are extremely important to our mission as a company," said Mark Paul, president of Stryker's neurovascular business. "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 TREVO 2 trial was a pivotal, randomized, core lab adjudicated clinical trial investigating the safety and efficacy of Stryker's Trevo Retriever for removing clots from ischemic stroke patients as compared to Stryker's current retriever, the Merci Retriever. The Trevo Retriever is the first device utilizing Stentriever technology, a novel method for retrieving clot from the neurovasculature of ischemic stroke patients. The TREVO 2 trial enrolled 178 patients in 27 institutions in the United States and Europe. Stryker obtained investigational device exemption (IDE) approval for the trial in December 2010 and began enrollment in the TREVO 2 trial in February 2011. The TREVO 2 data are being used in a 510(k) submission to the U.S. Food and Drug Administration (FDA) to seek clearance of the Trevo Pro Retriever.
For more information: www.stryker.com