Stryker's TREVO 2 Data Presented at European Stroke Conference

May 24, 2012—Stryker (Kalamazoo, MI) announced that Raul G. Nogueira, MD, presented the results of the TREVO 2 clinical trial at the European Stroke Conference in Lisbon, Portugal. 

TREVO 2 was a pivotal, randomized, core lab-adjudicated clinical trial investigating the safety and efficacy of the company's Trevo Retriever for removing clots from ischemic stroke patients as compared to Stryker's current platform, the Merci Retriever. The Trevo Retriever utilizes the company's Stentriever technology, designed 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 stated that it obtained investigational device exemption approval for the trial in December 2010 and began enrollment in the TREVO 2 trial in February of 2011. Dr. Nogueira, Director of the Neuroendovascular Division at the Marcus Stroke & Neuroscience Center in Atlanta, served as Co-Principal Investigator of the trial. Stryker advised that the TREVO 2 data are currently being used in a 510(k) submission to the US Food and Drug Administration to seek clearance of the next-generation Trevo Retriever device, the Trevo Pro Retriever. 

According to the company's press release, the study met the primary effectiveness endpoint, with Stryker's next-generation Trevo Retriever achieving significantly better post-device revascularization than Stryker's Merci Retriever (86.4% vs 60%). The rates of functional independence at 90 days for patients treated with the Trevo Retriever were also better than for the Merci Retriever (modified Rankin Scale ≤ 2, 40% vs 21.8%). Other measures of performance favoring the Trevo Retriever included improvement in the National Institutes of Health Stroke Scale 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.

“This new generation of mechanical thrombectomy device provides us with a highly effective tool for revascularizing large vessel strokes,” commented Dr. Nogueira in Stryker's press release. “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. 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,” said Co-Principal Investigator Helmi Lutsep, MD, Professor and Vice Chair of Neurology at Oregon Health & Science University in Portland, Oregon. “Now we need to find additional ways to quickly get patients having a severe stroke to a hospital that can provide comprehensive stroke care.”