In short
Last week saw the holding of the European Stroke Conference in Lisbon, Portugal, at which event Stryker announced the results of the TREVO 2 clinical trial comparing its Trevo® clot removal device with its current Merci® product. The Trevo® Retriever achieved significantly better post-device revascularisation than the Merci® Retriever.
Background
The TREVO 2 trial was a pivotal, randomised, 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 of 2011.
Revascularisation following use of the Trevo arm of the study was 86.4% compared to 60% in the Merci® 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% 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 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.
The TREVO 2 data are being used in a 510(k) submission to the U.S. Food and Drug Administration to seek clearance of the Trevo Pro Retriever.
Clinician comments
The results were presented by Raul Nogueira, M.D., Director of the Neuroendovascular Division at the Marcus Stroke & Neuroscience Center in Atlanta, GA. “This new generation of mechanical thrombectomy device provides us with a highly effective tool for revascularizing large vessel strokes,” said Dr. 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 & Science University in Portland, OR. “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.”
Company comments
“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.”
Source: Stryker Corporation, PR Newswire
published: May 29, 2012 in: Clinical Studies/Trials, Congresses and Meetings, Neuro, Stryker